Diagnostic Delay among New Smear Positive Pulmonary Tuberculosis Patients in Amhara Region, Northwest Ethiopia: A Two-Perspective Analysis Solomon Abebe Yimer Supervisors: Professor Gunnar Bjune MD, PHD CO - Supervisor Associate Professor Getu Degu University of Oslo Faculty of Medicine Department of General Practice and Community Medicine Section for International Health University of Oslo June/2004 Thesis Submitted in Partial Fulfillment of the Master of Philosophy Degree in International Community Health Abstract Delay in the diagnosis of tuberculosis (TB) causes more severe illness, more complication and an increased period of infectivity in the community. A study in Amhara region in 2001 showed that, among those who had history of cough of more than 3 weeks, only 30% visited the formal health care facilities. We hypothesized that there was a significant patients’ and health systems’ delay in the diagnosis of pulmonary TB in Amhara region, and this study was conducted to test our hypothesis. Objectives: To determine and analyze the length and associated risk factors of patients’ health providers’ and health systems’ delay among new smear positive pulmonary TB patients in Amhara region, Northwest Ethiopia. Methods: Within the setting of government health care facilities in Amhara region, we conducted a cross-sectional study from September 1 - December 31/2003. A total of 384 new smear positive pulmonary TB patients participated in the study. Patients were interviewed on the same date of the diagnosis using a semi-structured questionnaire. Result: The median total delay was 80 days (IQR 44-130 days) and the median patients’ delay was 30 days (IQR 15-90 days). Forty eight percent of the subjects delayed for more than one month. The median health providers’ and health systems’ delays were 61 and 21 days, respectively. In logistics regression, home distance >10 Km to a medical provider (adjusted odds ratio [ORadj] 3.81, 95% confidence interval [CI] 2.21-6.57) and selftreatment (adjusted odds ratio [ORadj] 1.69, 95% confidence interval [CI] 1.86-6.57) were associated with patients’ delay. Prior attendance to a health post/clinic (adjusted odds ratio [ORadj] 3.50, 95% confidence interval [CI] 1.86-6.57) and consulting private medical providers (adjusted odds ratio [ORadj] 2.10, 95% confidence interval [CI] 1.183.71) were associated with increased health systems’ delay. Conclusion: Delay in the diagnosis of pulmonary TB is unacceptably high in Amhara region. The delay is primarily related to the health providers. Accessing a simple and rapid diagnostic test for TB at the lowest health care facilities (health post/clinic) and encouraging a dialogue among all health providers are imperative interventions to reduce health systems’ delays. Besides these, due emphasis should be given to further decentralization of DOTS to the periphery and increasing public awareness of the disease among the population. Acknowledgement I would extremely like to thank the Norwegian Heart and Lung association (LHL) and the Norwegian Agency for Development Cooperation (NORAD) for providing me the financial support to conduct my study without which this project would not have been realized. My special thanks go to my main supervisor Professor Gunnar Bjune from the University Oslo for his critical comments and supervision from developing the project proposal up to writing up the final thesis. I would also like to thank my co-supervisor associate professor Getu Degu, from the Gondar College of Medical Sciences in Ethiopia for his advice to my project. I am grateful to the Amhara Regional State Health Bureau and the health departments and districts health offices in the region for their approval and coordination in conducting my study under their responsibilities. I sincerely appreciate the kind cooperation and contribution of all the patients who participated in this study. I would like also to express my sincere apreciatiation to all my data collectors namely; Geletaw Ayalew, Derib Asen, Mohammed Yesuf, Temesgen Birara Mesele Damte, Birhanun Melak, Bogale Dememe, Ayalew Asen, Mekonnen Amena, Azeb Tamirat, Abayinesh Alemu. Mahiteme Haile, Teshay Tarekegne, Asalif Demissie, Firehiwot Kassa, Betelhem, Alem Faris, Assefa Ali for their time and patience in interviewing patients. My heartfelt thanks go to Mette Klouman and Jens Henning Rygh from Norway and Dr Mohammed A/Rahim from Sudan for sharing ideas and valuable comments. I am also proud to include the contribution Dr Fekadu Abebe, Ingvild Dalen, Dr M.G. Farah, Yosef Abate, Alemu Kebede, Tesfaye Sisay, Dr Adane Bantayehu, Ayalew Endris, Getaneh Derseh, Dr Abebe Eshetu, and Tamirat Assefa for their various supports to my project. Finally, my deepest gratitude go to my parents, Abebe Yimer and Belayinesh Fantaw back home for taking care of my children while I was attending my study for a long time far away in Norway. I acknowledge the support and patience of my wife Engidawork Tesfaye and my children Yimrha and Natnael Solomon. I would like to thank also my brother Dereje Abebe, Biruk Haile and Birtukan Tesfaye from UK for their continuous encouragement and material support. Table of contents Chapter one: Introduction 1.1 Country profile 1.1.1 Ethiopia………………………………………………………………………….1 1 1.2 Tuberculosis in Ethiopia………………………………………………………...7 1.1.3 Background of the study area/Amhara region…………………………………..8 1.1.4 Tuberculosis in Amhara region………………………………………………...10 1.2 Back-ground and statement of the problem…………………………………….13 1.3 Literature Review…………………………………………………………………….15 1.3.1 Global burden of tuberculosis……………………………………………….....15 1.3.3 Reasons for increase……………………………………....17 global tuberculosis 1.3.4 The global tuberculosis control………………………………………………...21 1.3.4.1 What is DOTS strategy? ……………………………………………..21 1.3.4.2 Tuberculosis case detection…………………………………………..23 1.3.4.3 Tuberculosis suspects and case finding………………………………22 1.3.5 The importance of diagnostic delay in tuberculosis control…………………....24 1.3.6 What do we know about diagnostic delays? …………………………………...25 1.3.6.1 Differences in the definition of diagnostic delay…………………….25 1.3.6.2 Lengths of diagnostic behind diagnostic delays…………………………………………26 1.3.6.3 Reasons delays……………………………………26 1.4 Research questions, hypothesis and objectives of study……………….32 Chapter two: Subjects and methods 2.1 Study area/setting………………………………………………………………...34 2.2 Study design……………………………………………………………………...34 2.2 Population………………………………………………………………………..34 2.3 Sampling procedure and sample size…………………………………………….35 the 2.4 Data collection procedure………………………………………………………..35 2.4.1 Preparation for data collection…………………………………………36 2.4.2 Data collection method………………………………………………...36 2.4.2 Description of data……………………………………………………..37 2.5.3 Variables……………………………………………………………….37 2.4.3.1. Definitions of main variables………………………………………..38 2.4.4 Data quality…………………………………………………………….40 2.5 Data analysis……………………………………………………………………..40 2.6 Communication of results………………………………………………………..41 2.7 Ethical considerations……………………………………………………………42 Chapter three: The study results 3.1 Socio-demographic characteristics……………………………………………………...43 3.2 Initial symptoms, perception of illness and first action…………………………………47 3.3 Lengths and Associated risk factors of the different delays…………………………….49 3.3.1. A. All health providers considered as a reference point…………………………….. 50 3.3.1. A.1 The first health provider and the period of health seeking………………50 3.3.1. A. 2 Health providers’ delay………………………………………………….51 3.3.1. B. Only medical providers considered as a reference point………………………….54 3.3.1. B.1 Patients’ delay……………………………………………………………54 3.3.1. B.2 Medical providers’ delay………………………………………………...59 3.3.1. B.3 Health systems’ delay …………………………………………………...63 3.3.6. B.4 Diagnosing facility’s delay ……………………………………………...68 3.3.7 Total delay…………………………………………………………………….69 3.3.8 TB diagnosis in medical private providers……………………………………75 3.3.9 Stigma………………………………………………………………………….75 Chapter four: Discussion 4.1 The distribution of the sample population……………………………………………...77 4.2 The health seeking period and the health providers’ delay……………………………..77 4.3 Patients’ delay…………………………………………………………………………..78 4.4. Health systems’ delay…………………………………………………………………..81 4.5 Diagnosing facilitys’ delay……………………………………………………………...83 4.6 Total delay………………………………………………………………………………84 4. 7 The role of knowledge, perception and behavior in diagnostic delay………………….88 4.8 The contribution of the different health providers in diagnostic delay…………………88 4.8.1 Drug retail outlets……………………………………………………………..88 4.8.2 Traditional health care providers……………………………………………...89 4.8.3 Private medical providers……………………………………………………..90 4.8.4 Local injectors………………………………………………………………...91 4.9 Strengths, weaknesses and limitations of the study……………………………………..92 Chapter five: Conclusions and Recommendations 4.10 Conclusion…………………………………………………………………………….. 94 4.11 Recommendations……………………………………………………………………...94 4.12 Further research implications…………………………………………………………..96 References List of references Appendices List of appendices Appendix 1.Questionnaire for patients Appendix 2 Information about the research project Appendix 3 Declaration of consent for the study Appendix 4. Ethical approval document from the Regional Committee for Medical Research Ethics in Western Norway Appendix 5. Ethical approval document from the National Ethical clearance Committee in Ethiopia. Abbreviations AFB Acid fast bacilli AIDS Acquired immune deficiency syndrome ANC Ante-natal care ANRNHRB Amhara National Regional State Health Bureau BZHD Bahirdar Zonal Health Department CO Central office DOTS Directly observed treatment short-course Epi Info Epidemiology Program Office GNP Gross national product HIV Human immunodeficiency virus HIV/AIDS Human immunodeficiency virus/acquired immunodeficiency syndrome IMR Infant mortality rate IEC Information education communication IUATLD International Union Against Tuberculosis and Lung Disease MDT/DOT Multi-drug therapy/directly observed therapy MDR-TB Multi drug resistance tuberculosis MOH Ministry of Health MMR Maternal mortality rate NTLCP National Tuberculosis and Leprosy control Program PLHW People living with HIV RTLCP Regional Tuberculosis and Leprosy control Program SPSS Statistical package for the social sciences TB Tuberculosis TBMU Tuberculosis management units TLCP Tuberculosis and Leprosy Control Program U5MR Under five mortality rate UNESCO United Nations Educational Scientific and Cultural Organization UNHCR United Nations Higher Commission for refugees UNICEF United Nations Children Fund WTLCP Wereda Tuberculosis and Leprosy Control Program WHO World Health Organization ZTLCP Zonal Tuberculosis and Leprosy Control Program Explanations of words with specific meanings and written version of “Amharic “words frequently used in the text Birr: The Ethiopian national currency. At present, 1 Birr is equivalent to USD 0.12 or NOK 0.90 Debtera: An indigenous healer who receives his training from within the church (only men can become debtera). Dergue: The former military government of Ethiopia that ruled the country from 1974-1993. Kebele: The lowest administrative unit next to the woreda in the region with a population 3-5000. Local injector: An individual who practices administering injections to patients presenting to him/her without prescription from a formal medical provider. The procedure is usually performed behind closed door. Nefas/Bird: It is the” wind” which is believed to causes tuberculosis if one is exposed to it. Region: A semi-autonomous state (political administrative body) next to the central government of Ethiopia. Sanba-nekersa: Ethiopian word describing pulmonary tuberculosis. Tsebel Tsebel (holy water) are substances such as water, soil or ash, which are blessed in the name of a particular saint Woreda: It is more or less equivalent to a district with a population ranging from 90000-300000. Zone The second political administrative body next to the region with a population ranging from 500,000-3, 000,000. Chapter one: Introduction 1.1 Country profile (Ethiopia) A. Demography Ethiopia has an area of about 1 million square kilometers. The altitudinal variation in Ethiopia ranges from below sea level to 4300m above sea level. This offers numerous micro-climatic habitats ranging from tropical to near temperate zones. This coupled with the fact that man has inhabited the Nile valley for millennia could very well be the reason for the existence of several cultivated plants whose origin is believed to be Ethiopia. These plants include the cereals: Avena abyssinica (Ethiopian Oats) Elusine coracana (finger millets) and Eragrostis tef (teff), the oil crops: Guizota abyssinica (noog), Ricinus cummis (Castor oil plant), the starch plant: Enset ventricosum and the forage crop: Cynods aethiopicum (star grass) and the drug and fatigue plant: Catha edulis (chat) and Caffea arbica (coffee) (1). Ethiopia is a country with a current population estimated at 67 million of which more than 54 million (85.1%) live in rural areas. Ethiopia is one of the most populous countries in Africa ranking third after Nigeria and Egypt. It is a multiethnic society with approximately 100 ethnic groups contributing their own cultures and languages. The constitution of the Federal Democratic Republic of Ethiopia established a federal system of government with nine regional states and two city administrative councils. The role of the federal government is limited to directing the countries fiscal, defense, and foreign affairs and articulating economic and social policies and normative role in sectors of public services. The state governments are empowered to design and operate region specific programs and policies in the management of natural resources, primary and secondary education, health services and the maintenance of internal law and order (2). B. Economy The Ethiopian economy is classified into three categories: the agricultural sector dominated by peasant agriculture, the live stock sector dominated by nomadic pastorals and the modern sector which is in the process of coming into its own. Over 85% of the labor force is engaged in the first two sectors. With rapid population growth and the consequent rise of the population /land ratio, farm size per household has been declining over the years. Thus landlessness, particularly among the rural youth is becoming a serious problem. In fact, landlessness, which is a function of demographic and environmental factors is the major determinant of rural poverty. Among the consequences of landlessness is increased migration of landless youth into nearby cities, placing considerable pressure on urban social and economic services. The Ethiopian government has adopted an Agricultural Development led Industrialization (ADLI) policy and programs that recognize the interdependent relationship between agricultural and industrial development. The policy is directed to addressing the dual need for bringing about a relatively rapid structural differentiation of the economy and for dealing with the problem of food insecurity at both the household and societal levels. The problem of food insecurity represents a serious developmental challenge. While efforts in agricultural development are paying dividends in areas with abundant rainfall, Ethiopia has seen little progress in rain deficient areas. The strategy adopted for achieving a breakthrough in these difficult areas is to reduce dependence on rainfall and achieving acreage under irrigation, and engage in agricultural diversification (2). C. The social sector From the development point of view, the social sector is still week. National Health Service coverage is at 51 percent from about 30 percent a decade ago. The accelerated training of health professionals has yielded encouraging signs of deployment of health professionals to rural areas. The health system’s weakness lies primarily in its failure to bringing about behavioral change in the attitude of Ethiopians toward personal and environmental hygiene The education sector is undergoing rehabilitation. During most of the last decades of the 20th century, enrollment remained practically at a standstill but it has begun to increase since the turn of the current century. The new educational policy is geared to producing an educated workforce that will forge a dynamic economy. Ethiopia’s educational reorientation has led to greater emphasis on technical and vocational education at the secondary level (2). Table 1 Demographic and socio-economic characteristics, Ethiopia, 2002 ______________________________________________________________ Indicators Estimate ______________________________________________________________ Total population 67 million Birth per 1,000 population 44 Deaths per 1,000 population 15 Rate of natural increase (percent) 2.9 Infant mortality rate (per 1,000 births) 97 Total fertility rate 5.9 Percent of population below age 15 Percent of population over age 65 44 3 Life expectancy at birth 52 Percent urban 15 Adult literacy rate 39.1 Percent of combined 1st, 2n and 3rd level gross enrollment (99) 27 Gross national product in US$ 102 Percent of population not using clean water sources 76 Percent of children under five who are underweight 47 Percent population living under $ 1 a day 31.2 Percent of annual population growth between 2000 and 2005 2.4 Percent of population with health service coverage Percent of population with access to essential drugs 51 50-79 ______________________________________________________________ D. Health service in Ethiopia Modern health service More than 80% of the common diseases in Ethiopia are communicable (3). The conventional health system is underdeveloped and able to provide health service to about half of the population. Much of the rural population and a significant portion of the urban population have no access to any type of modern health care. There is an inability of the health care delivery system to respond qualitatively or quantitatively to the health needs of the population (3). In Ethiopia, there was no enunciated health policy until the fifties. Towards the end of the imperial period a comprehensive health service policy was adopted through initiatives from the WHO. However, the downfall of the regime precluded the possibility of putting this scheme to the test (4). The Dergue regime that came into power in the mid-seventies formulated a more elaborated health policy, a policy that gave emphasis to disease prevention and control, priority to rural areas in health service and promotion of self reliance and community participation. This policy worked in a centralized system. After the over-through of the Dergue regime in 1993, the new government adopted a new health policy, which gave emphasis to decentralization and democratization of the health service system (4). According to the recent health policy, modern health service in Ethiopia should be organized in a four-tier health care delivery system where there are primary health care units with 5-satellite health posts, each serving a population of 5000 at the periphery, and with a national referral hospital at the top meant to serve 5 million people. In the middle there are district and zonal hospitals. However, the new organization of health care delivery system is becoming hard to achieve as it costs a lot of resources (4). Considering the overall national requirements and the standard achieved in other countries, the available health infrastructures are below the desired level. There is still only one hospital for 584,500 persons, one health center for 272,400 persons and one health station for 22,800 persons (5). E. Health expenditure and health outcome Ethiopia has one of the worst health statuses in the world, and this is mainly due to the deteriorating socio-economic situation resulting in a low standard of living, poor environmental condition and inadequate health services. The need for an expanded and more efficient health sector in Ethiopia is overwhelming. As a proportion of gross-national product (GNP), Ethiopia’s public sector spending in 2001 (4.7%) was below the average for lowest income in Africa. In real terms this translates into less than US$ 1 per capita, which places it near the bottom in Africa (5). Among its health outcomes, Ethiopia stands out as having some of the highest levels of malnutrition (48% of children are underweight, 8% stunted, and 14% wasted). The infant mortality rate is a valuable indicator of health and development. Between 1998 and 2000, the infant mortality rate (IMR) reached 105/1000 live births and the under- five mortality rate (U5MR) accounted for 161/1000 live births. These figures are very high by world standards and Ethiopia remains among the countries in the world continuously classified as very high IMR and U5MR countries by United Nations Children’s Fund (UNICEF). Ethiopia’s maternal mortality rate (MMR) estimated at 5.82 per 1000 live births is significantly higher than all other developing countries (4).The present health status of the Ethiopian population has generally been aggravated by a low percapita share of public health expenditure, thus, low absolute level of health expenditure is clearly a constraint on health service delivery and in Ethiopia is far below estimates of what a basic package of health services would cost (less than US$ 13) (6). F. Traditional medicine in Ethiopia Traditional medicine is an age-old medical system practiced in all societies differing in level of usage. For centuries Ethiopians relied heavily on a system of health care containing both emperico-magical and magico-religious elements (1). The indigenous health care system is as diverse as the cultural diversity and as varied as the physical environment, which fosters unique flora, and fauna that are often used as prime tools of the trade in the struggle against a variety of health problems (1). Indigenous medicine in Ethiopia is heavily influenced by religious beliefs. Many of the cures that are used are derived from the Ethiopian Orthodox Church. While most of the saints in the church have specific healing practices associated with them, Mikael (for both men and women) and Mariam (for women) are probably most famous for their power to heal. When a person becomes sick, his friends and relatives may say to him, "Mikael must be with you. Mikael will protect you." Likewise, Mariam is said to protect the health of women, especially during childbirth. Even in cases where people seek bio-medical treatment, the eventual outcome of the treatment, whether complete recovery, continued illness or death, is often attributed to the will of the saint (7). Religious basis of indigenous medicine uses tsebel (holy water) as a treatment for various illnesses. Tsebel are substances such as water, soil or ash, which are blessed in the name of a particular saint. They are used as prophylaxes and treatments for a wide range of illnesses. In order for a tsebel to work, the sick person must be a devout believer in its effectiveness. If the tsebel fails to cure or protect against illness, the integrity of the patient's belief is challenged rather than the efficiency of the tsebel. One of the most powerful types of healers is the debtera, who receives his training (for only men can become debtera) from within the church. Whereas most indigenous healers' treatments are orally learned, practiced, and passed on, the debtera's knowledge is derived from a series of texts written for the most part in Ge'ez. These texts and the training that is necessary for their proper use are accessible only to selected men who have already completed their training for the priesthood (7). The other categories of traditional healers include herbalists. These groups of healers use plants to regulate organs, separate or expel the causative agents. More than 50% of the healers are herbalists. There are also other categories of healers including bone setters, uvula, and tonsil cutters, tooth extractors traditional birth attendants, cuppers and tattooists (7). As part of the community, traditional practitioners have over time developed very close relationships with the population in which they live. Their communication skills, easy access and spiritual healing have earned them respect and dignity (7). F. Traditional medicine and policy framework The first recognition of the practice of traditional medicine in Ethiopia was made in 1948 under the Medical Practitioners’ Registration Act (4). Recent policy guidelines prepared by the government include the drug policy. According to the guidelines of the policy (4): 1. Due attention shall be given to the development of beneficial aspects of traditional medicine including related research and its gradual integration into modern medicine 2. Traditional medicine shall be accorded appropriate attention by: Identifying and encouraging utilization of its beneficial aspects, coordinating and encouraging research including its linkage with modern medicine, developing appropriate regulations and registration for its practice. 3. Facilitate the gradual integration of traditional drugs with modern medicine by giving due attention to the traditional practices and identifying the beneficial and harmful aspects through investigation and research. 4. Attention shall be given to strengthening the sector through research and development. Research priorities shall be given to those traditional drugs which are in wide use. G. Integration of traditional medicine with bio-medicine In Ethiopia, both indigenous traditional medical practice and conventional medical practice are in operation and in most cases they conflict openly or covertly. Biomedical professionals have been known to be among the people who are very prejudiced against traditional healers and their medicine. There is also unwillingness on the part of the traditional medical practitioners to share their knowledge. Lack of recognition of traditional healers by the modern health care providers creates resentment and insecurity in the traditional healers leading to their alienation and isolation (9). 1.2 Tuberculosis (TB) in Ethiopia According to the Ministry of health (MOH) hospital statistics data, TB is the leading cause of morbidity, the third cause of hospital admission and the first cause of hospital death in the country. It is estimated that there are about a quarter of a million cases in the country and more than 40,000 persons die of TB every year (3). In Ethiopia, even though the effort to control TB was started in the early 1960s with the establishment of TB centers and sanatoriums in three major urban areas, there was practically no impact in reducing the toll of TB (10). After the introduction of the concept of National TB Control Programs (NTCP) by the World Health Organization (WHO), the MOH adopted this concept and subsequently opened the central office (CO) of the NTCP in 1976. From its conception, the CO had received neither sufficient budgetary nor manpower allocations and thus remained virtually non-functional. It was in 1992 that a standardized and well-organized TB control program incorporating Directly Observed Treatment Short-course (DOTS) was implemented in a few areas of the country. It has now reached a geographical coverage of 76 % of the entire country (10) In view of the remarkable achievements of the combined TB and Leprosy Control Program (TLCP) achievements in other countries, it was decided to combine the two programs in Ethiopia into the National TB and Leprosy Control Programs (NTLCP). The combined program under the coordination and technical leadership of the CO came into effect in 1994. The implementation of the combined TLCP began in 1997 with the development of TLCP manual. Before the inception of a TLCP in Ethiopia, little information was available about the extent of the TB epidemic. A national survey which was conducted from 19871990 estimated the annual risk of infection to be 1.5% (10). Currently, Ethiopia is one of the twenty-two high burden countries in the world and the second to the top in Africa (10). In the year 2001, the TLCP registered 94,957 cases of TB from the DOTS implementing areas, among which 33,028 were new smear positive pulmonary TB cases (36% of the total new cases). This represents a case notification rate of 173 and 60 per 100,000 populations for all forms of TB and new smear-positive cases, respectively. The increase is attributed to the expansion of DOTS in the country. By the end of the year 2001, the DOTS program covered 56 zones in nine regions and two administrative councils. Geographically, these zones represent 76% of the country, in which about 55 million (85%) people live (10) 1.1.3 The study Area (Amhara region) A. Demography The Amhara regional state is the second largest region of the country. It is located in the Northwestern part of the country and has a total surface area of 161, 828.4 Sq. kms (16% of the area of the country). The region shares boundaries with Tigray in the north, Oromyia in the south and Benishanngul Gumez in the west and Afar in the east. The topography of the region can be divided into two main parts namely the low- land and the high-lands (1500 meter above sea level). The highlands comprise the northern and eastern part of the region while the low land is mainly located in the Northwestern part of the region (11). Based on the 1994 population census of the region, the population in 2003 was estimated to be 17,740,521, out of which 8,880,262 (50.1%) were males and 8,860,259 (49.9%) were females. Among the total population of the region, 15,792,698 (89.02%) live in rural areas whereas the remaining 1,947,823 (10.98%) live in urban and suburban areas. Administratively, the region is divided into 11 zones, 113 woredas and 3500 kebeles. The kebeles constitute the lowest administrative unit within the woreda comprising an average population of 5000 inhabitants (11). B. Socio-economic characteristics The majority of the population lives below the poverty line. The housing condition in the region is very poor. In most cases a single room is used for dwelling for the entire family. Especially in rural areas, people share the same room with animals. The average household for rural areas is 5.5 and for urban areas is 4.5 while the total average household size for both areas is around 5. The dependency ratio among the age group 15-64 years of age is found to be 110 dependents per 100 persons. There are significant numbers of homeless people and street children. Currently their number is increasing at an alarming rate (11). Subsistence agriculture is the backbone of the region’s rural economy. Crop and live stock production are the major components of the agricultural sector. Farming is mainly rain fed and undertaken by traditional methods. The region has been exposed to repeated drought. On the other hand, the region possesses many tourist attractions like the rock-hewn Churches in Lalibela, the castles of Fasilledes and the Semein Mountains with its wild life. The United Nations Educational, Scientific and Cultural Organization (UNESCO) as parts of the world heritage has registered all of these. Moreover Lake Tana with its historical monasteries and churches, the Tisabay waterfall in the Blue-Nile are other tourist attractions in the region (11). With regards to communications, roads and air travel are the main means of transportation. There is one international airport at Bahirdar, which is the capital of the region. All weather roads cover approximately 10.2 km per 1000 sq km. Telephone, postal services and electricity are limited to the major towns of the region. The region has its own regional radio station and a weekly newspaper. There are also additional educational radio stations in 6 zones of the region (11). C. Health services More than 80% of the region’s health problems are attributed to communicable diseases. According to the health and health related indicators of the region (11, 12), malaria, HIV/AIDS and TB are the major deadly diseases in the region. The health service coverage is 41.1%, crude birth and death rates are estimated at 27.9 and18 /1000 live births, respectively. The prevalence of HIV among ANC attendants in the year 2001 was 24%. There are 14 hospitals, 78 health centers and 519 health posts currently active for the provision of health care to the population. The private sector is also actively engaged in rendering health care. In the region, there are 130 privately owned clinics with different levels, 40 drug stores, and 256 rural drug venders. TB patients are diagnosed at private clinics and referred to the government TB management units (TBMU) for the initiation of anti -TB chemotherapy (11). 1.1.4 TB control program in Amhara region A. Organization Structurally, until the year 2000, the regional TB and leprosy control program (RTLCP) was organized in the regional health bureau as a unit/section under the communicable disease control team within the former health programs department currently called as the disease prevention and control department. In 2001, the unit was upgraded to TB & Leprosy control and prevention team within diseases prevention and control department. The team comprises 3 health workers one team leader, senior expert (MD) and one RTLCP junior expert (nurse). Currently the team has two health workers, namely one team leader MD/MPH and one senior expert (MD) (13). The regional health bureau has a responsibility to control and supervise the Zonal Tuberculosis and Leprosy Control Program (ZTLCP) at zonal level, and the ZTLC is at the same time responsible for controlling TB and all other communicable diseases at the district level. Health officers in 72% of the zones staff the ZTLCP. At woreda level, there is one woreda TB and leprosy control (WTLC) expert on the malaria and other communicable diseases desk. However, the position is filled in only some woredas. In the majority of the woredas, nurses working at the TBMU in the health centers cover the position of the woreda TBLC coordination work. In 2002, TB was among the leading causes of morbidity and mortality in the region. A total of 6553 smear positive new cases were diagnosed. And the case detection rate was 41%. This was far less than the intended target of 70 %( 13). The TB and Leprosy control team in the MOH supports the TB control program in Amhara region technically and financially. The support includes among other things, anti-TB drugs, laboratory supplies and other expenses for training and review meetings. The regional health bureau also allocates budget for purchase of supplementary drugs at regular bases. B. Decentralization of DOTS in Amhara region DOTS strategy is being implemented in the region. Health centers and hospitals are serving as diagnostic and treatment units while clinics and health posts serve as treatment units (13). According to the regional health bureau, in 2002, there was a plan to decentralize the service to 65% of health units of the region. Each woreda and zonal administration was expected to reach the target set by the bureau by the end of the year. Accordingly, 4 zones achieved DOTS service decentralization to >65% of health units. These zones were namely Waghemera and Bahirdar 100% Oromia 75% and North Shewa 67%. However, the remaining 7 zones fail to achieve the target. Namely south Wollo 7.4%, north-Wollo 37%, west-Gojjam 41%, south Gondar 44%, north Gondar 46%, east Gojjam 49.5%, and Awie 52%. The reasons, for not achieving the planned target at a regional level in 2002 and in the above mentioned zones in particular were: the delay in releasing the budget from the MOH, time limits due to different campaigns (polio, and measles) and high turnover of health workers at different levels. Most importantly among the 11 zonal coordinators, 8 of them either moved to other position or began their postgraduate studies. The only 3 zones not affected were east Gojjam, Awi, and north Gondar zones. But these zones were among the campaign areas of the region. The bureau believed that, a combination of one or more factors as stated above has resulted in inhibiting the decentralization process as it was planned to achieve the target at district and zonal levels (10). For 2004 the regional health bureau’s plan is to reach an overall DOTS coverage of >85%. However, the bureau fears that the plan might not be achieved if adequate resources are not released on time from the MOH to the region (10). The regional health bureau also reported that it had encountered problems in the already decentralized areas. The major problems encountered according to the bureau were; poor recording and reporting, failure to send smear positive pulmonary patients for follow up sputum examination, failure to send feedback on the outcome of patients, directly observed treatment is not strictly observed as health workers may at times leave for some days closing the clinic, shortage of budget for collecting drugs/supplies from the WHO, lack of drugs monitoring and management system, high turn over of staff and related consequences (13). Quality control The regional health bureau started quality control on AFB direct microscopy in 1998. However, due to several limitations the activity was on and off until 2000. Since 2000 the regional health bureau has regularly been collecting slides from 6 zones. After 2nd rereading by the regional health and research laboratory, discrepant slides are submitted to the central reference laboratory for the third rereading. During 1996 only one discrepant slide was sent to the central reference laboratory. Based on the findings of the quality control on the slide, corrective measures were taken by the regional health bureau (13). 1.2 Background information and statement of the problem TB is a chronic infectious disease caused in most cases by Mycobacterium tuberculosis, an acid-fast rod-shaped bacillus. Occasionally, it can also be caused by Mycobacterium bovis and Mycobacterium africanum. It is transmitted by air and mainly affects the lungs (10). TB is a leading public health problem worldwide particularly in the developing countries. In view of the seriousness of the problem, WHO in 1993 declared it to be a Global emergency. Of the 1.7 billion people estimated to be infected with the TB bacillus, 1.3 billion live in developing countries. At the present time, it is estimated that there are 16 to 20 million cases worldwide with 8.74 million new cases every year. Two million of these people die every year. These constitute 26% of avoidable adult deaths worldwide (14). Globally, the burden of TB is increasing at an alarming rate. Various factors including poverty, population growth, migration and HIV/AIDS could be contributing to maintaining for the continued threat of TB in the world. But a significant problem lies with the fact that many cases remain undiagnosed (15). This could be due to various factors, principally found within the categories: patients delaying seeking health care or failure of the health care systems to timely diagnose patients. Delays in the diagnosis lead to an increased period of infectivity in the community. It is estimated that an untreated smear positive patient may infect on average more than 10 contacts annually and over 20 during the natural history of the disease until death (16). Delayed diagnosis also causes patients to have more severe disease, more complications and lead to higher mortality (16). This hits families in the developing world very hard, particularly because younger active productive age groups are the chief victims of the disease. Delays in the diagnosis of TB have been reported in both industrialized and developing countries and vary considerably, from 6.2 weeks in Australia (17) to 12 weeks in Botswana (18) and 16 weeks in Ghana (16). A number of factors have been identified that appear to influence delay in diagnosis and commencement of treatment. These include the individual’s perception of the disease, the severity of the disease, access to health services, and the expertise of health personnel (19). In all delay studies conducted so far, conflicting reports exist on how patient socio- economic characteristics, gender and the health services affect diagnostic delay. Besides this, the already available information regarding diagnostic delay has been evaluated to be inadequate at a consultative meeting that was held in Geneva in 2000 (20). Delay in diagnosis has been observed in Amhara region, North West Ethiopia. An unpublished community based survey which was conducted in 2001, revealed that, among those who showed the main symptoms of TB for more than 3 weeks, only 30% visited the formal health care facilities (21). This might show that a significant number of patients are not correctly diagnosed, or prefer to go to other health providers, or fail to seek appropriate health care at an early stage of the disease. Therefore, there was an urgent need to investigate this problem so as to improve the case finding activities in the region. And hence the current study was conducted. In Ethiopia, two studies were conducted on delay in TB. One was conducted in southern Ethiopia in a hospital setting (22) and another one in 1998, in the capital city in a health center setting (23). Both studies assessed patients’ and health system’s delays by taking diagnosing facilities as the first level of health care contact for patients seeking health. The roles of other health providers were not included in their studies. As the health service coverage in the country is very low (<50%), a number of people use other options to get health care for their health problems (3). These include the various categories of traditional health care practitioners and others. Taking this reality into account, the current study has managed to incorporate all health providers known to be potential venues for patients seeking health. Therefore, considering the importance of implementation research, which has an important role in increasing our knowledge of the factors affecting diagnostic delay, this study was conducted to examine diagnostic delay among smear positive pulmonary TB patients in Amhara region, Northwest Ethiopia. The researcher believes that, this study, by including all health providers as potential venues for seeking health care has managed to collect relevant information regarding the health seeking behavior, lengths and risk factors of delay both from the patient and the provider side. It is hoped that, the regional TB control program will use this information to improve the current low case detection rate in the region. 1.3 Literature Review 1.3.1 Global burden of TB Despite effective treatment, TB remains a major public health problem on a global scale. Due to its frequency, its transmission pattern and its potential effects, TB has significance to public health that exceeds most other diseases. TB today may infect anyone by breathing in the air where a TB patient has coughed, sneezed, talked or spat. Left untreated, each person with active TB will infect on average between 10-15 people every year (24). From the global perspective, TB is perhaps the greatest infectious killer of all time. It is the seventh most important cause of mortality worldwide and the fourth most important cause of death in developing regions. Over centuries, it has taken over one billion lives (25). TB today is estimated to cause about 2 million deaths and 8.74 million new cases yearly (26). TB causes more than 26% avoidable adult (15-59 years of age) deaths in the developing world, which results in tremendous social and economic costs. The WHO has identified 22 high burden countries that account for 79% of all TB cases worldwide, and all of them are low or middle-income countries (25). According to the WHO, the NTCPs reported that, by the end of 2002, 69% of the world’s population lived in countries, or parts of countries, covered by DOTS. DOTS programs notified 3.0 million new cases, of which 1.4 million were smear positive. A total of 13.3 million TB patients and 6.8 million smear-positive patients were in DOTS programs between 1995 and 2002 (26). The distribution of TB is very uneven in the world. Of the estimated 8.74 million cases emerging globally each year, only 5 percent occur in the industrialized countries. In these countries, the bulk of infected persons are found among the elderly, while in most low-income countries, the large majority of infected persons are in the economically most productive and reproductive age groups (27). TB accounts for 8.4% of healthy years of life being lost among men and 7% among women. The economic costs of TB in terms of lost production are therefore considerable. Further studies show that TB is concentrated in lower socio-economic groups, in households least able to cope with the burden (25). Globally, the prevalence of infection is thought to be similar in males and females. There is an estimated 2:1.1 male to female ratio of cases notified to public health authority worldwide. However, the rate of developing active disease from a primary infection with M. tuberculosis (progression rate) may be greater among women of reproductive age than men of the same age (25). As the leading infectious killer of youth and adults, TB kills more women than all causes of maternal mortality combined (15). From a public health perspective, TB is a high priority disease because of the tremendous burden it imparts and the existence of interventions of proven efficacy that are some of the most cost effective we have (28). Since 1994, WHO has recommended and scaled up the TB control strategy, brand named as DOTS (directly observed treatment short course). Other global initiatives, which have recently emerged in response to the global TB crisis are stop TB, the Global Alliance for TB Drug Development, the TB Diagnostic Initiative and the TB Vaccine Initiative (25). The goals of TB control are to reduce mortality, morbidity and transmission of the disease, while preventing drug resistance, until TB no longer poses a threat to public health. It also aims to reduce human suffering and the social and economic burden families and communities have to bear as a consequence. To achieve this, it is necessary to ensure access to diagnosis, treatment and cure for each TB patient and to protect vulnerable populations from TB and its drugresistant forms (29). 2.2.2 Reasons for Global TB increase A. Demography TB is a disease concentrated in lower socio-economic groups, and increasing economic inequalities together with population growth creates an increase in TB cases. People’s life expectancy is also increasing and as a result, any increase in resources has been absorbed by an increase in cases (30). Demographic factors have played a major role in the global re-emergence of TB. Childhood mortality rates have declined much more rapidly than birth rates over the past 30 years, resulting in dramatic increase in the size of adolescents and young adult population in the world. The population mostly of poor countries has increased. The highest incidence of TB across the world is in central Africa and southern Asia, particularly in India, where the population increase is known to be the most rapid. Current annual population growth in these countries is about 100 million, which means that global TB incidence in absolute numbers will continue to increase by around 100.000 cases every year. In Ethiopia, the population is rapidly increasing at a rate of 2.9% every year (31). This contributes to the increased incidence of TB in the country. B. TB and HIV Factors associated with resurgence of TB in many countries include HIV epidemic. Infection with HIV leads to extensive destruction of the immune defense mechanisms of the body. As a result, those infected with HIV become ill with severe and often deadly diseases to which persons without HIV infection would not usually be susceptible (24). Throughout the industrialized and the developing world, TB and HIV are closely linked in mutually disadvantageous synergy: HIV infection promotes the progression of TB infection to disease, and TB accelerates the course of HIV. HIV infection greatly increases the likelihood that infection with M. tuberculosis, either recent or latent, will progress to active TB. In fact, HIV infection may be the most potent risk factor for TB yet identified. Conversely, TB is the most common cause of death in persons with HIV infection in the world (24). Globally, TB is the leading cause of HIV-related morbidity and mortality. In developing countries, HIV-infected people run an annual risk of 5-15% of developing TB. At least one in three people living with HIV (PLWH) will develop TB (32). The escalating TB case rate over the past decade in sub-Saharan Africa is largely attributable to the HIV epidemic (33). In 1997, the prevalence of M. tuberculosis and HIV co-infection worldwide was 0.18% and 640,000 incident TB cases (8%) had HIV infection. It was estimated that in the year 2000, the global incidence of HIV-positive TB cases was 12 %. The number of people living with TB and HIV co-infection was 16.3 million. Of the estimated 2 million TB deaths in the world, about 0.5 million deaths were HIV- positive TB cases (32). SubSaharan Africa bears the highest burden of HIV positive TB cases followed by south East Asia (32). In Ethiopia, even though there are not many studies conducted to analyze the impact of HIV on TB, few studies have documented that about 40% of adult TB cases in urban areas are HIV-positive (10). C. Poverty Poverty has been strongly associated with the incidence of TB. Low socioeconomic indicators tend to result in crowded living conditions, conditions that are conducive to increased transmission of tubercle bacilli should a case occur, resulting thus in a generally higher prevalence of TB infection with subsequent increased incidence of the disease. Poverty may also reduce access to health care services, thus prolonging the period of infectiousness of TB patients and further increasing the risk of infection among the contacts of such a patient (34). Social and economic trends have contributed to the spread of TB. Over the past 10 years the number of less developed countries has doubled while GNP in some middle-income countries has decreased. This has meant a decrease in the availability of resources for TB control programs. Poverty, malnutrition and overcrowding have for a long time been recognized as the main predisposing factors for TB. It is estimated that about one third of the world’s population is infected with TB but far from every body gets sick. The immune system walls off the TB bacilli, which are protected by a thick waxy coat and they can lie dormant (inactive) for years. When one’s immune system is weakened, the chances of getting sick are much greater. The strength of the immune system is related to nutritional status, hygienic conditions, susceptibility to other infection as well as access to health care and vaccination throughout a lifetime (25). From the late 19th century, improvement of socio-economic conditions contributed more to the large decline in the prevalence of TB in industrialized countries than all the medical interventions did. In the industrialized countries today, this is again manifested through it has become a rare disease in the population in general but is getting more prevalent among certain minority groups, as well as among homeless people, alcoholics and drug abusers (34). Even if we see an increase of TB among some groups in industrialized countries, the burden of TB is mainly carried by developing countries where 95% of all cases of the disease and 98% of all deaths due to it occur (30). In Ethiopia, majority of the population live in absolute poverty. This creates a favorable condition for the increase of TB incidence in the country. As described earlier, the burden of TB in Ethiopia is one of the highest in the world. At the center of the problem is the back ward socio-economic development resulting in one of the lowest standard of living (9). D. Movement and migration of people Population movement in the form of migration of labour, general migration, armed conflicts and refugee movement is more common to take place now a days. In recent years, TB has become confined to definable population groups, such as disadvantaged populations; immigrants from countries with a high prevalence of TB, refugees, the elderly, homeless, substance abusers, persons in correctional facilities and nursing homes. A high incidence of the disease in these groups is not unexpected because the rates are higher in lower socioeconomic groups. Poverty leads to bad and overcrowded housing or poor conditions. These may lower defenses as well as making infection more likely. People living in these conditions are often badly nourished, suffer from alcohol abuse or drug addiction. The whole complex of poverty makes it easier for M.tuberculosis to cause the disease. As a result of poverty, the actual number of refugees as well as displaced people in the world is increasing. Untreated TB spreads very easily in crowded refugeecamps, prisons or between groups of homeless living together under poor conditions. Homeless usually live in poor conditions. In addition, it is difficult to treat migratory and homeless groups, as treatment takes at least six months and close supervision. According to the WHO, as many as 50% of the world’s refugees may be infected with TB, and forced movements of immigrants and refugees contribute to the spread. The increasingly global nature of trade, air traveling and the rapid movement of people across the world represents additional risks of spreading the infection (32). According to the United Nations Higher Commission for Refugees (UNHCR) (31), there were an estimated 20 million refugees, displaced and needy people in 2003. Many refugees originate from countries with high TB incidence rates. Poor nutrition and health mean that refugees are at particularly high risk of developing TB. In Ethiopia, as a result of rural poverty landless people are being displaced. Due to HIV and other socio-economic factors the number of street children is increasing. Besides these, the country had been in a civil war for a number of years as a result a number of people had been displaced. These all have created a favourable ground for the increased transmission of TB in the country. F. TB and drug resistance During the past 4 decades, NTCPs have failed to reduce TB transmission. Health policies in most low and middle in-come countries have not given priority to TB control. In adequately funded programs have led to an increase in the pool of chronic infectious sources. The overwhelming problem with the treatment of TB is that cure takes months of treatment. The great majority of TB patients in the world have poor health care facilities. Therefore, patients do not complete their treatment. Premature stop of the treatment for TB results in relapse and the emergence of drug resistance (34). Poor management of TB causes resistance to anti-TB drugs. From a public health perspective, treatment poorly supervised or incomplete treatment of TB is worse than no treatment at all. Widespread occurrence of multi-drug resistance TB (MDR) would constitute a major threat to controlling TB in resource poor countries (35). This is because TB patients with resistant organisms may not respond to standard treatment; remain infectious for longer periods of time and spread resistant organisms to others. Most patients will require expensive second line drugs. And in settings where resources are already inadequate, control will be further compromised. There is no mystery about the causes of drug resistance. It is a man-made consequence of poor patient management, including improper prescription, non-compliance, lack of control of drug distribution and irregular drug supply (30). Studies have been conducted on drug resistance in different countries of the world. In 2000, an estimated 273,000 of the 8.7 million new TB cases (3.2%) were multi drug resistant. In A drug resistance survey carried out in 64 countries the highest MDR proportions among new cases were found mostly in Eastern Europe, Russia and china. An estimated 70% of new MDR cases were found in only 10 countries (36). In Ethiopia, periodic surveillance of drug resistance is lacking. Few studies conducted have reported resistance to one or more anti-TB drugs that ranged from 15% to 37% (37, 38). 2. 2.3 The global TB control 2.2.3.1 What is DOTS strategy? In 1993 the World Health Organization declared TB a global emergency, and created a framework for TB control (39). In 1994, the WHO together with the International Union against Tuberculosis and Lung Disease (IUATLD) launched the DOTS strategy to fight TB. This five-pillar strategy has been proven to be cost effective in some studies (40). And it is now recommended world wide as a solution to the “Global emergency”. From the time DOTS was introduced on a global scale, over 10 million infectious patients have been successfully treated (29). The targets for global TB control by the year 2000, ratified by the World Health assembly were to successfully treat 85% of the detected smear positive TB cases and to detect 70 % of all such cases (41). However, these targets were not achieved as planned and the target year has been re-set to 2005. The WHO estimates that in the year 2000, 55% of the worlds population lived in countries or parts of countries covered by DOTS. Global case detection of smear positive cases detected under DOTS calculations of the cure rate show an 80 % treatment success rate in DOTS areas and a 22% cure rate in non DOTS areas (25). A recent prediction shows that at the current pace of case detection, the TB control goals will not be reached until 2013 (42). The major challenge is for TB endemic countries to accelerate case detection, while still maintaining high cure rates. DOTS is one of the most cost effective health interventions, compared to those available for other diseases. As part of the DOTS strategy, health workers counsel and observe their patients swallowing each dose of a powerful combination of medicines. The health system is required to observe that all patients take their medication, to monitor their progress, ensure that all bacilli are gone, and to document that they are cured. The package has other components in a five-point policy package. These components include the following (10), 1. Government commitment to sustained TB control activity 2. Case detection by sputum smear microscopy among symptomatic patients self- reporting to health services 3. Standardized treatment regimen of six to eight months with directly observed therapy (DOT) 4. A regular and un interrupted supply of all essential anti-TB drugs 5. A standardized recording and reporting system that allows assessment of treatment results for each patient and of the TB control program performance overall. 2.2.3.2 TB case detection Case detection under DOTS refers to the proportion of TB cases that are diagnosed and reported within a DOT program divided by the assumed TB incidence. Since the true incidence of TB in a given population is rarely known, calculations of case detection are based on estimates of the true incidence of TB. Different methods are used for estimating TB incidence, including extrapolation made from assumed annual risk of infection and information from sentinel studies (43). The way to reach the target of 70% case detection is through passive case finding. Passive case detection refers to the absence of active initiation from health care providers i.e. the patient reports him or herself to health care providers as opposed to active case detection, where health care providers actively screen for TB in the population (44). The success of passive case detection is thus highly dependent on both the patient health seeking behavior and the awareness among health providers of symptoms suggestive of TB and the possibility to act on them (44). On the other hand, if increased case detection is to have an effect on the TB epidemic, high cure rates are necessary. The WHO recommends national TB control programs to first ensure a sufficiently high cure rate level and after that expanding the program in terms of case detection (45). The way to reach the set target of 85% cure rate, once adequate chemotherapy is available is according to the DOTS strategy, to ensue patient compliance by direct observed therapy. This component recommends observation of each intake of TB medication at least during the first two months of treatment (45). 2.2.3.3 TB suspects and passive case finding The diagnostic methods recommended in the DOTS strategy focus on identifying sputum smear positive cases of pulmonary TB. The WHO and IUATLD have recommended that all individuals with cough lasting for more than three weeks should be offered TB diagnostics, i.e. a sputum smear examination when seeking health care in TB high prevalent setting (45). Thus, long-term cough together with sputum production are key features of the TB suspect case. Other general symptoms of pulmonary TB are fever, weight loss and night sweats together with additional respiratory symptoms like haemoptysis, cough, chest pain or dyspnea (45). According to the guidelines of the national TB control program, examination of sputum by direct microscopy for the presence of acid fast bacilli (AFB) in all self presenting persons with symptoms suggestive of TB must be performed (10). Also, an assessment of the close contacts of patients of a smear positive pulmonary case should be done. Other important activities that must be carried out to improve the effectiveness of passive case finding activity include; public education on the importance of early self-reporting for examination and treatment whenever there are symptoms suggestive of the disease, training of general health staff on prompt recognition of the signs and symptoms of the disease & making quality diagnostic and treatment services accessible to all communities in the country (10). 2.2.4 The importance of diagnostic delay in TB control According to Rieder (2000), to ultimately reduce the incidence of TB in a community, the primary epidemiological aim of TB controls is to reduce the pool of persons with TB infection. Without intervention future cases of TB will emerge from this pool. Principally, there are two supplementary lines of action to accomplish this objective. The first is the interruption of transmission from newly occurring infectious cases of TB with appropriate chemotherapy as swiftly as possible after their occurrence, and the second line of action is the prevention of TB cases before they occur with preventive therapy of sub clinically infected persons. The first line of action will reduce the incidence of infection and the second will reduce the prevalence of infection (46). Rieder further elaborated that, between the onset of transmissibility and its arrest, there could be a delay of the patient in seeking medical attention and the delay of health care provider in making the diagnosis and commencing appropriate chemotherapy. These delays are variably attributable to the patients’ attitude towards symptoms and the health care providers’ ability to rapidly diagnose TB (46). For the patient, delay can occur during the process of noticing symptoms, determining if one is ill, assessing the need of professional care and overcoming social, personal and physical barriers to obtaining that care. For the health care system, the differential diagnosis can expand or become more focused depending upon key pieces of information. For instance, a physician who has a high clinical suspicion of TB and an AFB smear positive sputum result will probably initiate treatment more quickly than one with low clinical suspicion and an AFB smear negative result. Further more, the clinician may begin by considering diagnoses other than TB (47). Globally, delays in diagnosis have been studied in many countries in different settings and many different findings have been observed. In the following, detailed accounts of the different lengths and risk factors of diagnostic delays are presented. 2.2.5 What do we know about diagnostic delays? 2.2.5.1 Differences in the definition of diagnostic delays According to Rieder (2000) diagnostic delays refer to the delay period related to the patient and the health care provider before diagnosis and commencement of treatment. When it comes specifically to patients’ delay, various definitions might be given (46). For example, in the study that was conducted in an urban health center setting in the Gambia (19), patients’ delay was defined as the period from onset of the major symptoms to first visit to a health provider. The delay period diagnosing facilities’ delay. The health provider in this study included traditional healers, market drug sellers, pharmacists, village health workers, friends and relatives as well as medical staff. Whereas in the Ethiopian study which was conducted in a similar setting, patients’ delay was defined as the interval between the onsets of the major symptoms to the first consultation to a health care facility (23). The delay period was divided again into three namely; patients’ delay, health services’ delay and total delay. In this study, unlike the Gambian study, consultations with traditional healers and other forms of health providers were not included. In the Ethiopian study, this implies that, the delay is related to the patient unless he/she visits a modern health care facility either in the private sector or publicly owned health care facilities. From the Gambian study, the lesson is that, the patient should not be blamed as long as he/she visits anyone of the health providers based on the above definition, i.e. the delay is because of other providers not because of the patient. As for the health systems’ delay, in most of the studies it was defined as the period from first visit to a medical facility to initiation of anti-TB treatment (18, 23, 48). However, the Gambian study in this regard used health providers’ instead of health systems’ delay to refer to the period from first contact to a health provider to first initiation of treatment (19). Regarding the cut off point for an acceptable patients’ and health systems’ delays, the studies reviewed had no standard cut offs. Most studies used a onemonth period of delay as an acceptable patients’ delay (18, 23, 48). But, one study from New York used 2 months as an acceptable patients’ delay (47). Other studies used the median delay as a cut off point to dichotomize the samples into shorter or longer delays (16, 47). As for the health systems’ delay, in the majority of the studies, the acceptable delay ranged from 10 days to 2 weeks (47, 23). However, one study from Canada used 1 week as an acceptable delay (49). The decisions on the various cut offs were made by a consensus among treating physicians in the respective areas where the studies were conducted (47, 50). In general, we can observe from the above examples of studies that, the definitions and the cut offs used for patients’ and health systems’ delay were not similar. This might be related with the settings in which each of the studies were conducted. 2.2.5.2. Lengths of diagnostic delays The different studies conducted in various areas of the world have shown variability in the lengths of diagnostic delays. For example, studies conducted in Botswana (18), Ethiopia (23) and Ghana (16) have shown a median patients’ delay of 3 to 8 weeks and a health systems’ delay of 1 to 5 weeks and the total delay was 9 to 16 weeks. The longest median patient’ delay was recorded in Tanzania, which was 23 weeks (50). The least 0.3 weeks was recorded in the Gambia (18). As to the proportion of patient’ delay, among the studies reviewed, the highest was seen in Tanzania in which 85% of the study subjects delayed for more than one month (50) and the lowest 20% was recorded in Malaysia (51). 2.2.5.3 Reasons behind diagnostic delays A. Lack of knowledge It is well established that knowledge plays an important role in shaping the health seeking behavior of individuals. Studies have shown that patients who do not know the symptoms and treatment of TB had longer period of delays compared to those who know (23, 50). In many places, the symptom of cough is not openly recognized as possible TB until accompanied by more serious symptoms such as haemoptysis and weight loss (52, 53). In Kenya for example, the patient's main defining factor for TB was that, symptoms were persistent. Therefore, making early recognition of the disease impossible (53), as a result TB was confused with other conditions including asthma, pneumonia, cancer, malaria and AIDS (53). In Colombia, TB symptoms were seen as part of a flue-like condition until accompanied by haemoptysis or weight loss (52). B. Alternative explanation of the symptoms of TB In certain parts of the world, symptoms of TB, such as cough, could be attributed to certain traditional folk conditions. For example in Malawi, possible causes of cough were believed to be tsempo, mphumu or mdulo, which are traditional conditions believed to cause cough, chest pain and weight loss either for the patient or a member of their family. The cause of such conditions is believed to be careless sexual behavior such as adultery or having sex in taboo situations (54). TB, which is thought to be acquired by bewitchment or the breaking of sexual taboos. In such instances it is believed only traditional healing could help the patient. In Colombia, patients were found to attribute TB symptoms to flu initially. When symptoms persisted, a folk complex called grippa pasmada was the usual explanation. This grippa pasmada (unripened flue) could be caused by exposure to sudden temperature changes or desmande (being drenched by rain) (52). In the Philippines, children with TB symptoms are believed to have a folk illness, piang, which is due to injury to the skeletal or muscular system, and is treated by massage (55). In Mexico, coughing, fatigue, loss of weight and back pain were all attributed to gripe, bronchitis or a folk illness called susto. Similarly in Kenya, early symptoms were often overlooked or confused with malaria or a common cold (53). In Vietnam, patients identified four types of TB. Hereditary TB; affecting women and caused by worry. Physical TB; affecting men and caused by hard work. And Lung TB; contagious and mainly affecting men (56). In Ethiopia, TB symptoms were associated with bird (57). C. Socio-demographic factors Gender In most areas of the world, more men than women are diagnosed with TB and die from it. TB is the leading infectious cause of death among women. Studies have reported gender differentials showing significant variation of patient and healthy systems delays. For example, a study conducted in Ghana (16) showed, females had increased patients’ delay compared to males. In over half of the patients, the doctors’ delay exceeded the patients’ delay. Doctors’ delay was significantly increased in females. Median doctors' delay was three times longer for females than males. In a study that was conducted in Kenya, it was found that, the mean patients’ delay among women was 5.4 weeks and among men 3.8 weeks (50). In Vietnam (58), a study showed doctors’ delay of 5.4 weeks for women and 3.8 weeks for men. Evidence from Nepal suggests that, there are a higher proportion of women than men with TB who remains undiagnosed in the community (59). Women are reported to have longer delays than men between onsets of symptoms and presenting for treatment, only doing so when their symptoms severely interfere with their daily activities (60, 61). In most low- and middle-income countries, the women are only one third of the total notified cases. This could be explained by the following hypothesis: higher exposure to infection among men and under diagnosis among women due to socio-cultural and economic reasons (58). Age Previous studies (20, 48) have shown that, the age of the patient may affect health-seeking behavior. For example, older age >45 years was a risk factor for delayed presentation (44). In Ethiopia those within the age group 24-34 were found to experience longer delays compared to the lower age groups (22). Occupation In some studies, the type of occupation of the patient was found to affect early presentation. A previous study that was conducted in Ethiopia showed that, the married ones, farmers and soldiers were reported to have been delayed compared to students (20). Another study from Botswana showed a median health systems’ delay of 5 weeks. One of the significant risk factors associated with health systems’ delay was marriage (18). Education “Level of education” in some studies was found to affect the health seeking behavior of patients. Individuals with no formal education had longer delay (22); patients with education less than 9 years were significantly delayed (58). In Tanzania (50), patients with education below primary level were characterized as having a longer delay. In Malawi (62), 43% of the patients were only aware of their diagnosis at the time of receiving their smear results, and lack of schooling was a significant risk factor in this study. Area of residence In order to encourage early presentation for treatment, the treatment offered must be accessible to the patient. A study conducted in an urban Ethiopian setting in 1998 showed that, the smear negative patients who lived >1 hour walking distance from the health center were at risk of delaying more than 30 days after the onset of symptoms (23). In Tanzania, those that lived > 10 Km away from a health facility had longer delay compared to those that lived <10 Km to a health facility (50). In a study that was conducted in Ghana (16), doctors’ delay was significantly increased in rural patients. The median doctors' delay was 3.9 times greater for rural patients compared to urban dwellers. Another previous study from south Ethiopia showed that patients who lived in rural areas presented late for treatment (22). Stigma Possibly stigma is contributing further to all the other factors for delayed presentation for treatment. This stigma is primarily caused by the contagious nature of the disease, leading to a certain amount of social isolation. TB patients become ostracized by peers and also within families, for example, being made to eat separately and with different utensils (60, 61). In Pakistan (60), India (61) and Ethiopia (63) TB may lead to divorce. For instance, 29 % of divorces in Ethiopia is said to be due to TB (64). For unmarried women, TB jeopardizes their marriage prospects (59, 60). Among the Zulus in Africa, the contagious nature of the disease paired with a belief in witchcraft leads to increased social stigma. To suggest a person with TB may spread the disease is said to be tantamount to identifying that person as a witch or sorcerer, since only such people have the power to spread disease (55). The association of TB with poverty adds to the stigma of the disease. In Vietnam for example, TB is seen as a dirty disease caused by bad hygiene and TB patients report a lack of respect from their peers (58). In some parts of Africa, TB is becoming synonymous with a diagnosis of AIDS, contributing further to the stigma of the disease. For example, in a study that was conducted in Zambia, 49% strongly agreed that coming to the clinic for TB makes other people think that the person has AIDS. However, the fear was not associated with delay (64). Health service factors The quality of the health service given at health care facilities may have an impact on health care seeking and the speed of diagnosis. Many studies have evidenced diagnostic delays attributable to poor quality of health care. For example in Zambia (64), poor perception of the health services (particularly expectation of lack of drugs and previous experience of the clinic) was found to be an important factor for delayed presentation. In Colombia (52), staffs at health centers have been shown to share the same beliefs and definitions of TB as patients. The symptom of back pain would not cause the doctor to investigate respiratory symptoms. Nurses only invite patients with haemoptysis, cough, weight loss and fever to attend TB clinics, and use signs of poverty in patients’ appearance as a useful case finding method. Most patients attended some medical practitioner once they diagnosed grippa pasmada, and received prescriptions for flue (52). TB diagnosis was delayed due to the narrow opening times of the laboratory for delivery of sputum samples (52). In Kenya (53), patients mentioned being incorrectly diagnosed at their first consultations with health centers, hospitals and dispensaries. In Ghana (16), there was an almost perfect correlation between median doctors’ delay and rates of failure to perform sputum microscopy. There was also a strong correlation with low rates of diagnosis. The median doctors’ delay at rural government clinics and private institutions was significantly longer than that of the central hospital doctors’ delay. The rates of failure to perform sputum microscopy at these institutions were much higher than for the central hospital. In some studies, prior attendance to health posts and village health workers was associated with longer health systems’ delays. For instance, a study done in Gambia (19) showed a median health providers’ delay of 8.3 weeks and median diagnosing facilities’ delay of 0.2 weeks. First contact with village health worker was a risk factor in this study. Another study from Botswana (18) showed a median health systems’ delay of 5 weeks (mean: 12.2 weeks). Delayed sputum examination was common despite the prolonged productive cough duration reported by patients. One of the significant risk factor associated with health systems’ delay was, first visit to a health post and traditional healers or faith healers. In Ghana (16), 65% of the study subjects consulted traditional healers first. In Tanzania (50), > 38 % of the study subjects primarily consulted traditional healers before presenting to a formal medical facility. In Malawi (62), 70% attended traditional healers first. In some studies, first visit made to private medical providers was found to be associated with longer delays in diagnosis. A study done in Kuala Lumpur, Malaysia (51) found that TB was not considered in most patients when they consulted their private practitioners and essential investigations such as sputum examination and chest x-ray were often not done. Reasons for patients presenting to private practitioners before public doctors are (65): 1. Greater ease of access 2. Shorter waiting periods 3. Longer or more flexible opening hours 4. Better availability of staff and drugs 5. More sensitive health worker-client attitudes 6. Greater confidentiality in dealing with stigmatized conditions such as TB, more compatible with people’s expectations and cultural beliefs. Cost of health care There is considerable cost to both the patient and to the health service in implementing an efficient TB treatment program. The main costs to the health service are generally: sputum examination, drugs (where paid for by health service), inpatient care (where required), supervision and follow up and health education. The main costs to the patient are; cost of seeking alternative treatments before diagnosed with TB, loss of work, travel expenses, costs during any hospital stay required and social costs such as divorce and removal of children from school (66). In Uganda, a study showed that approximately half the monetary costs to patients were incurred before diagnosis when patients were seeking different forms of treatment. It is likely that this is the case in many countries as initially self-medication and consultation with private practitioners are common (66). Generally, from the above studies we can understand that, delays in diagnosis have been common problems among pulmonary TB patients in many countries. It has been evident from these studies that, the choices of first health provider, the time of health seeking, the speed of diagnosis at health care facilities and the risk factors varied from one country to another. This may imply that knowledge of country specific health seeking behavior of patients as well as socio-cultural and health service information are vital for understanding the magnitude of diagnostic delays. WHO as stated previously has evaluated all the available information regarding diagnostic delay at a consultative meeting that was held in Geneva in 2000 and has came to the conclusion that, the already available information regarding diagnostic delay is insufficient to address the problems of delay, and has recommended operational research directed at generating additional information regarding the health seeking behavior, patients’ and health systems’ delays (20, 67). Besides this, a joint TB and leprosy review that was conducted in partnership with WHO in October 2002 in Ethiopia has recommended that, increasing case detection remains a priority that must be tackled through a combination of efforts (68). Therefore, our study was conducted in response to these international and national calls in addition to the local problems addressed earlier in this chapter, and we believe that, the findings of our study may contribute in filling the gap in knowledge about diagnostic delays from the Ethiopian perspective. 2. Research questions, Hypothesis & Objectives Research question 1. What is the duration of patients’ health systems’ and total delay? 2. What are the predictors of delay, in particular, socio-demographic factors, lack of knowledge of TB symptoms and treatment, preference to private health care, social factors like HIV/TB associated stigma etc? Hypothesis 1. There is a significant patients’ and health systems’ delay in the diagnosis of pulmonary TB in Amhara region. 2. Socio-demographic factors are the main predictors of delay. General Objectives To investigate patients’, health providers’ and health systems’ delays in the diagnosis of pulmonary TB in Amhara region, Northwest Ethiopia. Specific objectives 1. To determine the time delay from onset of the major symptoms of TB to first visit to a health provider, 2. To estimate the time delay from first health provider visit to first initiation of treatment. 3. To estimate the time delay from onset of the major symptoms of TB to first visit to a medical provider 4. To determine the time delay from first medical provider visit to first initiation of treatment. 5. To identify the risk factors influencing the time delay among patients and the health care system in the diagnosis of pulmonary TB in Amhara region. 1 1 . Health providers any person consulted by the patient about his /her sickness that gave or prescribed some thing (what ever the form) for treatment. This does not include the family 2. Medical providers modern health care facilities, including health centers hospitals and clinics either government or privately owned. Chapter two: Subjects and methods 2.1 Study area (setting) The study area was the Amhara regional state. The study was carried out in 5 hospitals and 15 health centers. All were governmental health facilities with TBMUs. In the region, there is no a well-established referral system. Therefore, TB patients can go to either a hospital or a health center to seek for health care depending on their choice. 2.2 Study design The design was institution based cross-sectional study. Cross-sectional surveys aim at quantifying the distribution of certain variables in a study population at one point in time and the measurement of exposure and effect are made at the same time (69). 2.3 The study universe (Study population) Here is how we defined our universe for the study. Pulmonary TB patients in Ethiopia Target Population: New smear positive pulmonary TB patients in Amhara region Study population: New smear positive pulmonary TB patients presenting to TBMUs in the region from September 1 - December 31/2003 During the study period a total 1092 smear positive pulmonary TB cases were diagnosed in the region. We studied 384, which hold 35.2 % of the total diagnosed cases in the region. The inclusion criterion Subjects were included in the study if they were new smear positive pulmonary TB patients and above 15 years of age. Exclusion criterion Subjects were excluded from the study if they were smear negative, relapsed or failed treatment cases. 2.4 Sampling procedure and sample size In order to select representative sample of the study population, a multi-stage sampling procedure was followed. First, we selected 6 zones randomly out of the 11 zones of the region. Then, we listed all hospitals and health centers that are found in the selected zones, and among the listed health institutions, we randomly selected five hospitals and fifteen health centers (a total of 20 TBMUs) as the final study sites. Finally, we interviewed subjects right after diagnosis consecutively until the intended sample size was achieved. Sample size determination The sample size was calculated using the formula required for determination of sample size for estimating proportions described as follows (70). n = z2 pq d2 where q = 1-p n is the sample size, z is the z value, which is 1.96, and P is the proportion, d² is the margin of error. Therefore, by taking a previous study done on patients’ and health service delay in Ethiopia, which showed 58% proportion of delay of more than one month (22) and a 95% confidence interval and a margin error of 5%, the sample size was calculated to be 373, and when 5% was added for nonresponses and other loses, the total sample size was 392, and these were selected from the 20 health facilities in the study area. 2.5 Data collection procedure 2.5.1 Preparation for data collection The first step in the data collection procedure was to secure ethical clearance from the Ethiopian Science and Technology Commission. For this purpose, we had to submit 6 copies of the research proposal and other required documents to the commission. Then, we waited for some time until decision was made. After 1 month of submission of the project proposal, we got the ethical clearance letter from the commission. The second step was to communicate with the ANRSHB regarding our project. To accomplish this, we went in person to the bureau at Bahirdar, which is 560 Km away from the capital Addis Ababa and discussed about the project with the respective officials in the bureau. They were very much delighted with the project and happy to help us with the available resources and gave us an official letter of permission to conduct the study in the region. The third step was to go to each of the six zones where the selected health facilities are found. We went in person and did the same thing like we did in the regional health bureau. The zonal health department heads were happy to collaborate with our project and gave us letter of permission to conduct our study in the health facilities that are under their control. To reach at the final study sites (health facilities), we had to go to each of the woreda health offices where the selected health care facilities are found. Finally, after we got permission from each of the woreda health offices, we went to each of the selected health institutions to commence the data collection activity. The last preparatory steps were to recruit interviewers, conduct training and pretesting the data collection instrument. We selected a total of 22 data collectors (health officers) who were working at the study sites. The data collectors were trained for three days. After the training, pre-testing was conducted in 5 health facilities to test the data collection instrument. After the pre-test, a discussion was held among the data collectors and the researcher. Following the discussion, the original questionnaire was shortened and modified slightly. 2.5.2 Data collection method In order to collect the intended data for this study, a questionnaire was used. Most of the questions were closed-ended. There were also some open-ended questions. Generally, structured questions with closed-ended questions are commonly used in cross-sectional studies. However, there are some limitations in using it. Like for example, important information may be missed, because spontaneous remarks made by respondents are not recorded or explored. On the other hand, open-ended questions permit collection of in-depth information and exploration of spontaneous responses by respondents. However, the interviewer may inadvertently influence the respondents and open-ended data are qualitative and thus are relatively difficult to analyze (69). 2.5.3 Description of data/data collection For each patient socio-demographic variable, major presenting symptoms of pulmonary TB, duration of major presenting symptoms and the date of first health care visit were included. The major pulmonary symptoms asked were presence of cough for more than 3 weeks, production of sputum, chest pain and haemoptysis. Other closed-ended questions regarding knowledge of TB were also included (See annex-1). During the interview, if a patient had weakness for over a year, but was seeking medical care for a cough of one month duration, the latter was taken as the duration of illness. All smear positive cases in the selected health institutions were studied until the representative sample size was achieved within the study period. The actual data collection commenced on September 1, 2003 and ended on December 31, 2003. 2.5.4 Variables Dependent variables: 1. Patients’ delay 2. Health providers’ delay 3. Medical providers’ delay 4. Diagnosing facilities’ delay 5. Health systems’ delay 6. Total delay Independent variables: Socio- demographic variables: sex, age, marital status, religion, ethnicity Socio-economic variables: occupation, educational status, income and distance from health facility Health service factors, formal health providers, non-formal health providers, presenting symptoms 2.5.4.1 Operational definitions of variables TBMU: A health care facility where microscopy for AFB is done and anti -TB chemotherapy is initiated. Total delay: The total time (measured in days) from reported onset of major symptoms (cough, haemoptysis) to commencement of anti-TB treatment. Health systems’ delay: The period (measured in days) from first visit to a medical provider to first initiation of anti-TB treatment. Medical providers’ delay: The period (measured in days) from first visit to a medical provider to reporting to a TBMU Health seeking period: The period (measured in days) from onset of the major symptoms of TB to first visit to a health provider Patients’ delay: The period (measured in days) from the onset of the major symptoms (cough, haemoptysis, etc) to first visit to a medical provider. Health provider: Any person consulted by the patient about his /her sickness that gave or prescribed some thing (whatever the form) for treatment. This does not include the family. Health providers’ delay: The time (measured in days) from the first contact to a health provider to the first time anti-TB chemotherapy is initiated Diagnosing facility’s delay: From the time (measured in days) the patient reported to a diagnosing facility till the first time the patient starts anti-TB treatment. Formal health providers: Modern health care facilities; such as health centers clinics, hospitals either government or privately owned. Non-formal health providers: These include traditional healers, herbalists and religious healers, (holy water) and drug retail outlets. . Traditional health providers: These are traditional healers, herbalist, religious healer (holy water). Drug retail outlets: These are pharmacies, drug stores, rural drug venders and open market drug sellers Income: Income was divided into 4 categories; no income, irregular income, regular income 1-300 Birr and regular income above 301Birr. Housewives, students and the unemployed were categorized as no income group. Farmers are categorized in the irregular income group and self-employed were categorized in either of the two regular income group by calculating their total income on monthly basis. Knowledge: knowledge is information or fact that an individual is aware of. In this study, it was defined based on the awareness of the patient about the symptoms and treatment of TB. Stigma: Feeling of disapproval that TB patients experience due to their illness in their day-today life within the community. 2.5.5 Data quality As described earlier, questionnaire was used for data collection. The original English version was translated into Amharic for the actual data collection. The Amharic version was back translated into English to check the consistency of the translation. In general, Quality of data was assured through the following methods; Careful design and translation of the questionnaire Pre-testing and standardizing of the questionnaire Proper training of interviewers Continuous check ups of data collection procedures through intensive supervision Patient register cards and TB registration books and laboratory registries were cross-checked 2.6 Data analysis After the data collection was completed successfully, the data were entered into a computer and routine checking and cleaning were preformed. The statistical package Epidemiology Program Office (Epi-Info) version 6 and statistical package for the social sciences (SPSS) version 11.0 were used for analysis. Percentages and proportions were calculated to show the distribution of the population by socio-demographic characteristics. To determine the lengths of the patients’, health systems’ and total delay; medians, means, inter-quartile range were applied. When assessing the risk factors for patients’, health providers’ health systems’ and total delay, the median delay period was used to dichotomize the sample in to either shorter or longer delay period. Group differences were compared using Mann-Whitney, Kruskal-Wallis (more than two groups) and chi- square tests. Ninety-five percent confidence interval and odds-ratio were used to assess the associated risk factors of the different delays. A p-value of less than 0.05 was considered statistically significant. Finally, after all the potential covariates were first identified by univariant analysis, logistic regression analysis was performed to assess the relative impact of predictor variables on the outcome variables. When assessing knowledge of respondents about TB, six questions were posed, and a score was calculated from the awareness part of the questionnaire. Awareness regarding TB was assessed from two angles, i.e. their knowledge about treatment of TB and the seriousness of the disease. In the treatment part, subjects were asked three questions including whether TB is curable or not, fee for treatment and duration of treatment. If they believed that TB can be cured, the assumption is that they might be willing to seek treatment. Concerning the seriousness of the disease, subjects were asked about causes of TB, risk of patients and people around them if they were not treated. For each of the six questions, a value one was given if responded correctly and a value zero if responded incorrectly. Then, the mean and the inter-quartile scores were calculated. Finally, the score was divided into high knowledge and low knowledge. Respondents that fall in to the third quartile were given a value one and considered to have high knowledge and the other given value two considered to have low knowledge. Then it was cross-tabulated with the main outcome variables for possible associations. When assessing stigma associated with TB/HIV, six questions were again posed to the respondents. Each question was given a value one if answered correctly and a value zero if answered incorrectly. Then the mean and inter quartile scores were calculated. Respondents that fall in to the third quartile were given a value one and considered to have less stigmatizing experiences and the others given value two and considered to have high stigmatizing experiences. Then, it was cross-tabulated with the dependent variables to look for possible association. 2.7 Communication of results The study result will be presented as a master’s thesis at the institute of general practice and community medicine at the University of Oslo, Norway. One or two articles presenting the results will be submitted to international journals and local journals in Ethiopia, the results of the study will also be presented to the regional TB control program in the Amhara Regional State Health Bureau. 2.8 Ethical consideration The project proposal was evaluated by relevant Ethical Committee in Norway and the Ethiopian Science and Technology Commission. Both bodies have ethically cleared the project. Before the interviewing was commenced, the purpose of the study was clearly explained by the interviewers for every participant of the study including how the interview was going to take place. Great respect was given to the study subjects. The patients were fully empowered to decide on their willingness to participate in the study. Moreover, the study subjects were assured that there would not be any risk of participating in the study. Their willingness to participate in the study was confirmed by taking their informed consent. Both written and oral consent systems were employed depending on the level of education of the study subjects. For the purpose of confidentiality, during the analysis of the records, names and identifying features were coded to protect their privacy and after an interview was over, the questionnaire was kept in a locked cabinet. The entire interview was conducted in a private room in the health care facility. Taking into consideration how interviewing is tiresome for the patient, we were very much careful not to use more than the intended time of 20-30 minutes. All of the patients recruited for the study volunteered to participate in our study. Chapter three: Results In this chapter, we will start describing the findings of our study first by presenting the socio-demographic characteristics of the study population and then, we will mention how the subjects perceived their illness initially and the actions they took on their own in response to the symptoms. Following this, we will look into the different delay periods and the associated risk factors. This data is presented in two ways. In the first part, all health providers are taken as a reference point to calculate the health-seeking period and the health providers’ delay. In the second part, only medical providers were considered to calculate the patient’s, medical providers’, diagnosing facilities’, health systems’ and total delay. We believe that, this structuring of the result section might give a better understanding of our material to the reader. 3.1 Socio-demographic characteristics In this study, a total of 384 new smear positive pulmonary TB patients were interviewed from September 1 – December 31/2003. The socio-demographic characteristics of the respondents are summarized in table 2. The proportion of males slightly exceeds that of the females with a ratio of 1.19: 1. The mean age was 29.8 ±10.52 SD years with a median age of 28 years, minimum 16 and maximum of 70 years. The mean age for males and females was 30.1 and 29.6 years, respectively. Most, 95.9%, of the subjects were in their productive age (15-54 years old). Married group constituted the highest proportion compared to the others. There was sex-related significant difference in marital status among the sample population (² = (3) 42.2, P< 0.001). Eighty-five out of one hundred eighty two (46.7%) females were married compared to 55 (27.2%) males. On the other hand, 98 out of 202 (48.5%) males were single compared to 36 (26.9%) females. This difference was again statistically significant (² = (2) P= < 0.001). The majority (97.1%) of the sample population belonged to the Amhara ethnic group and the proportion of christians was higher compared to the other religions put together, and the difference was statistically significant (² = (2) P= < 0.001). Table 2 Socio-demographic characteristic of smear positive pulmonary TB patients in Amhara region _____________________________________________________________________ Characteristics Number % _____________________________________________________________________ Sex Male Female 202 182 52.6 47.4 127 155 61 25 13 03 30.1 40.4 15.9 6.5 3.3 0.8 134 89 140 21 34.9 23.2 36.5 5.5 373 11 97.1 2.9 270 137 70.3 29.7 157 145 72 10 40.9 37.8 18.7 2.6 170 104 59 51 44.3 27.1 15.4 13.3 104 86 59 35 55 45 27.1 22.4 15.4 9.1 14.3 11.7 Age 15-24 25-34 35-44 45-54 55-64 >65 Marital status Never married Divorced Married Widowed Ethnicity Amhara Others Religion Christian Muslim Education Illiterate 1-8 grade completed 9-12 grade completed 12+ Monthly income (Birr) No income Irregular income Regular income1-300 Birr Regular income >301 Birr Occupation Farmers House wife Civil servants Students Unemployed Self-employed Number of children No children 164 42.7 1-3 197 51.3 4-6 16 4.2 >7 7 1.8 Distance ≤10Km 216 56.3 >10Km 168 43.8 ________________________________________________________________________ In this study, we found that 78.6% of the sample population was below the level of 8th grade (table 2). The distribution of educational status among the sample population showed significant difference (² (2) = 25.4 P <0.001), and specifically when education was analyzed against sex, the difference was significant with females being more illiterate compared to males (table 3). Table 3 Education and marital statuses compared with the sex of smear positive pulmonary TB cases in Amhara region. Variable Male Female Total P- value ________________________________________________________________________ Education Illiterate 69 (34.2%) 88 (48.4%) 88 (40.9) ² (2) =25.4 P < 0.001 th 1-8 grade 84 (41.6%) 61 (33.5%) 61 (37.8) >9th grade 49 (24.3%) 33 (18.1%) 33 (21.3) Marital status Never married 98 (48.5%) 36 (19.8%) 134 (34.9%) ² (3) =42.2, P< 0.001 Divorced 45 (22.3%) 44 (24.2%) 89 (23.2%) Married 55 (27.2%) 85 (46.7%) 140 (36.5%) Widowed 4 (2.0%) 17 (9.3%) 21 (5.5%) ______________________________________________________________________ The findings also showed that, fifty six percent of the respondents resided within 10 km radius of a medical facility. As for the type of house used for dwelling, 39.1% lived in a hut and 60.9% lived in an ordinary corrugated sheet iron roof house. The houses in both cases had an average room number of one. The average family size was 5, and in 51.3% of the households, the number of children ranged from 3-5. Among the total respondents, 44.3% did not have any form of defined income. However, among those who had regular cash income, the average monthly income was 250 Birr, which is equivalent to USD$ 29.0 based on the current market. In general, the distribution of income among the sample population showed statistically significant difference (² (3) =146.3 P < 0.01), and specifically when respondents’ income was cross-tabulated with the sex of the respondents, we found that more females were in the no income group compared to the males. The proportion was 61% verses 36 % and the difference was statistically significant (table 4). Table 4 comparisons of the respondents sex with income among smear positive pulmonary TB cases in Amhara region _____________________________________________________________________ Variable Male female P-Value ______________________________________________________________________ Income No income 74 111 Irregular income 83 31(² (3) =146.3 P < 0.01) Income 1-300 Birr 19 17 Income above 301Birr 26 23 ______________________________________________________________________ In this study, female respondents were asked whether they could decide on their own regarding where to go for help during their illness, 327 (85%) responded that they could decide on their own. Subjects were asked also to describe if they had ever smoked, consumed alcohol or chewed khat and their response was cross-tabulated against the duration of illness before seeking help from the medical providers. The result showed that there was no statistically significant difference among these groups with regards to patients’ delay (table 5). Table 5 Chi-square test showing comparisons of patients’ delay with current habits among smear positive pulmonary TB patients’ in Amhara region _______________________________________________________________ Delay No delay Characteristics ≤ 30 days > 31 days p- value _______________________________________________________________________ Smoking Yes 8 4 No 191 181 0.45 Drinking alcohol Yes 18 12 No 181 173 O.45 Khat chewing Yes 21 31 NO 178 154 0.10 ______________________________________________________________________ 3.2 Initial symptoms, perception of illness and first action The major symptoms that patients experienced during the course of their illness are presented in figure 1. As can be seen on the graph, cough was the most frequent symptom, followed by tiredness. Figure 2 shows chief complaints by patients. In 60.7% of the cases, cough was also the chief compliant for presenting to health providers. Figure (1): Graph showing the major presenting symptoms among smear positive pulmonary TB patients in Amhara region. 120% 96.4 % 100% 80% 76.0 % 79.4 % 90.6 % 92.2 % 85.2 % 86.5 % yes 3.6 % no 13.5 % ss lo a of e pp t ea ss w ts s os in pa e tit sis ty op e dn 7.8 % l ht t es 14.8 % g ei ch er m ae h ug v Fe H co 9.4 % e tir 20.6 % gh ni 24.0 % 25.0 % w 60% 40% 20% 0% 75.0 % Figure (2): Chief complaints of smear positive pulmonary TB patients in Amhara region. , 70% 60% 50% 40% 30% 20% 10% 0% 60.7% 25.8% 10.2% 0.5% 1.0% 0.5% 1.0% 0.3% ss dne Tir g at in we ht s nig ss t lo igh we tite n pai s ysi ppe fA so Los r est Ch ve Fe opt h em Ha ug Co When subjects were asked to describe what might have caused the symptoms at the onset of their illness, only 17.5% of the respondents attributed their illness to TB. Most (82.3%) suspected that they had other diseases. Of these, the most frequent suspected cause was wind blow (locally called nefas) (Figure 3). The mechanism of causation was believed to be that the wind penetrates the chest as one is exposed to it and then reaches the lungs causing TB. Figure 3 Perceived self-diagnosis among smear positive pulmonary TB patients in Amhara region 70% 60% 50% 40% 30% 20% 10% 0% 61.4% 17.5% 6.3% 5.2% 6.5% 2.3% No TB Dx iti s ch on Br ia ar al M s fa Ne a m th As As to the first action taken during the onset of cough, 46.9% of the respondents reported that they had tried self-treatment to cure their illness. They used traditional homemade remedies to lessen their cough and enhance the smooth expectoration of the sputum. The types of remedies used were, various plant and animal products including steam inhalation (table 6). According to the respondents, the duration of the treatment ranged from 5 to 8 days. Table 6 Lists of local remedies used for treatment among smear positive pulmonary TB Patients in Amhara region ________________________________________________________________________ Types of treatment Number % ________________________________________________________________________ Hot fluids (atmit, suf, telba) 97 25.3 Honey, row egg yolk, Garlic 49 12.7 Steam inhalation 28 7.2 Goat meat (fat), ocholoni 14 3.6 No treatment taken 204 53.1 3.3. Lengths and associated risk factors of the different delays 3.3.1. A. All health providers considered as a reference point 3.3.1. A.1 The choice of first health provider and the period of health seeking After trial of home treatment and as the symptoms persisted, patients started seeking health care from different health care providers. Of all the respondents, 61.7% initially visited non-formal health providers and 38.3% visited the formal medical providers. The decision about where to go for help was influenced in the majority (88%) of cases by close family members. Friends and health professionals also took part in influencing 44 (11.3%) the patient. Almost all patients had visited a health care provider in one-month time from the onset of their symptoms. The type of the specific health provider visited during the initial period of the illness is presented in figure 4. Figure 4 Pie chart showing first health providers visited by smear positive pulmonary TB patients in Amhara region 3.60% 9.90% 9.40% 27.10% Traditional providers Drug retailoutlets HC 3.90% Hospitals PMP 15.10% 31% Local injectors Cli/HP Key PMP: private medical providers, CLi/HP: Clinic or Health Post, HC: Health Center A general analysis was performed to assess the relationship of selected sociodemographic variables with the choice of first health provider. For this purpose, two groups were formed, Formal and non-formal health providers. Those who first visited medical providers were categorized under formal and those who first visited non-formal health providers were categorized under non-formal health providers, and these groups were cross-tabulated against the socio-demographic variables. The result showed that students (ORadj=0.32, 95%CI 0.11, 0.90) and those with educational status of 9th grade and above (ORadj=0.42, 95% CI 0.23, 0.81) were less likely to visit the non-formal health providers. Otherwise, the choice of health providers did not vary according to other variables (table 7) Table 7 Relationship of choice of health providers with socio-demographic characteristic among smear positive pulmonary TB patients in Amhara region. _____________________________________________________________________________ Visited formal visited non formal Crude Adjusted Characteristics health provider health service OR (95%CI) OR (95%CI) _____________________________________________________________________________ Sex Male Female Age 15-24 25-44 >45 Education Illiterate 1-8grade >9 grades 83 64 119 118 1:00 1.28 (0.85, 1.94) 1:00 1.09 (0.66, 1.81) 56 73 18 71 143 23 1:00 1.50 (0.98, 2.40) 1.00 (0.49, 2.01) 1:00 1.33 (0.82, 2.17) 0.83 (0.38, 1.78) 48 55 44 109 90 38 1:00 0.72 (0.44, 1.16) 0.38 (0.23, 0.66) * 1:00 0.78 (0.46, 1.32) 0.42 (0.23, 0.81) * Residence >10 km ≤ 10 km Occupation Farmers Housewives 60 87 108 129 1:00 0.82 (0.54, 1.24) 1:00 1.07 (0.64, 1.79) 38 24 66 62 1:00 1.48 (0.80, 2.75) 1:00 1.2 3(0.49, 3.17) Civil servants 30 29 0.55 (0.29, 1.06) 0.87 (0.30, 2.51) Students 22 13 0. 34 (0.15, 0.75) * 0.32 (0.11, 0.90) * Unemployed 19 36 1.09 (0.55, 2, 16) 1.00 (0.39, 2.50) Self employed 14 31 1.27 (0.60, 2.69) 1.47 (0.55, 3.97) Single 50 84 1:00 1:00 Divorced 34 55 0.96 (0.55, 1.67) 0.73 (0.40, 1.35) Married 52 88 1.00 (0.61, 1.64) 0.71 (0.40, 1.25) Marriage Widowed 11 10 0.54 (0.21, 1.36) 1.02 (0.49, 2.01) Income No income 64 121 1:00 1:00 Irregular income 44 70 0.84 (0.51, 1.30) 0.71(0.33, 1.54) Income 1-300Birr 13 23 0.93 (0.44, 1.97) 0.86 (0.33, 2.24) Income above 301 Birr 26 23 0.46 (0.24, 0.88) * 0.49 (0.18, 1.36) Knowledge Low 51 109 1:00 1:00 High 96 128 0.62 (0.40, 0.95) * 0.79 (0.48, 1.27) Stigma Low 57 76 1:00 1:00 High 90 161 1.34 (0.87, 2.06) 1.41 (0.92, 2.24) _____________________________________________________________________________ * Significant at 0.05 ** Adjusted for socio demographic factors In general, the median time from onset of cough to first visit to a health provider was 15 days, (IQR 25-75 days) and the mean was 17.3 days. 3.3.1. A. 2 Health providers’ delay The median and mean health providers’ delay were 61 and 86.4 days respectively. IQR was 31-116 days. The cumulative distribution showed that 9.6% of the respondents had a median health providers’ delay of 15 days and for 50 % of the respondents, the median health providers’ delay took 60 days (figure 5). We observed significant difference between those that first visited the formal health providers and those that visited the nonformal health providers (Mann-Whitney test; P< 0.001) (Table 8). Moreover, details of the influence of the type of health provider on health providers’ delay are presented in table 9. Table 8 Choice of first health provider and its influence on the health providers’ delay, among pulmonary TB patients in Amhara region. _______________________________________________________________________ Health providers Median (IQR) P-value ________________________________________________________________________ Formal 43 (80-159) Non formal 80 (80-159) < 0.001 _____________________________________________________________________ Table 9 Choice of first health provider and its influence on the health providers’ delay among smear positive pulmonary TB patients in Amhara region. _____________________________________________________________________ N Median delay (IQR) Health provider ______________________________________________________________________ Traditional health care 104 89.5(47-168) (Herbalist, holy water) Drug retail outlets 119 88 (38-148) Health posts 58 54 (24-83) Health centers 36 35 (21-81) Hospitals 15 36 (17.5-61) Private clinics 38 37(25-110) Local injectors 14 78 (42-146) ______________________________________________________________________ A further detailed analysis was performed to look into the association of sociodemographic and health services factors with the median health providers’ delay (table 10). The results showed that those who lived within 10 Km radius of a medical facility (ORadj =0.42 95%CI, 0.24, 0.72), those who went to school 1-8th grade (ORadj= 0.56 95% CI, 0.33, 0.97), those who were 9 th grade and above (ORadj= 0.40 95% CI, 0.20, 0.81) and those who attended formal health providers initially (ORadj=0.35 95%CI, 0.20, 0.81) were less likely to have longer health providers’ delay. On the other hand subjects between the age group 25-44 had experienced longer health providers’ delay. In the univariat analysis civil servants (ORadj=0.41 95%CI 0.21, 0.78), students (ORadj=0.25 95%CI 0.11, 0.59), Self-employed (ORadj=0.48 95%CI 0.24, 0.99) and those with income above 301 Birr (ORadj=0.39 95% CI 0.20, 0.76) seemed to have lesser risk of increased health providers’ delay. However, when doing multivariate (logistic regression analysis) these tendencies lost significance. Table 10 The associations of socio- demographic and health service factors with health providers’ delay among smear positive pulmonary TB patients in Amhara region. Characteristics Sex Male Female Age 15-24 25-44 >45 Residence >10Km 10Km Occupation Farmers Housewives Delay >62 days No delay Crude ≤61 days OR (95%CI) 1:00 1.39 (0.93, 2.08) 1:00 0.89 (0.51, 1.53) 80 97 17 1:00 0.20 (1.33, 3.27) * 2.40 (1.17, 4.92) * 1:00 2.04 (1.21, 3.4) * 2.02 (0.88, 4.60) 110 80 58 136 1:00 0.31 (0.21, 0.47) * 1:00 0.42 (0.24, 0.72) * 60 55 45 42 1:00 1.31(0.72, 2, 34) 1:00 0.87 (0.32, 2.44) 21 38 0.41(0.21, 0.78) * 0.45 (0.13, 1.53) 9 24 0.25 (0.11, 0.59) * 0.33 (0.10, 1.08) Unemployed 27 23 0.71(0.37, 1.36) 0.78 (0.29, 2.09) Self employed 18 27 0.48 (0.24, 0.99) * 0.45 (0.15, 1.3) Single 59 75 1:00 1:00 Divorced 39 50 0.99 (0.57, 1.70) 0.89 (0.45, 1.6) Married 85 55 1.96 (1.2, 3.17) 1.61 (0.87, 2.94) 14 0.64 (0.24, 1.67) 0.60 (0.19, 1.83) 55 80 59 1:00 0.43 (0.27, 0.69) * 0.21 (0.12, 0.37) * 1:00 0.56 (0.33, 0.97) * 0.40 (0.20, 0.81) * 94 100 1:00 0.31 (0.20, 0.47) * 1:00 0.35 (0.21, 0.57) * Civil servants Students 94 96 108 86 47 119 24 Adjusted OR (95% CI) Marriage Widowed 7 Education Illiterate 102 1-8th grade 65 9th and above 23 Health provider visit Non formal 143 Formal 47 Income No income Irregular income 98 56 87 58 1:00 0.85 (0.54, 1.36) 1:00 0.65 (0.28, 1.54) 1-300 Birr 21 15 1.24 (0.60, 2.56) 2.11 (0.77, 5.7 >301birr 15 Medical provider Clinic/HP 38 Health center 86 Hospital 25 Private medical provider41 34 0.39 (0.20, 0.76) * 0.79 (0.26, 2.41) 39 77 27 51 1:00 1.14 (0.67, 1.97) 0.95 (0.47, 1.92) 0.89 (0.45, 1.51) 1:00 1.08 (0.56, 2.06) 1.29 (0.56, 3.00) 1.26 (0.61, 2.60) ___________________________________________________________________________ * Significant at < 0.05 * * Adjusted for socio/demographic and health service factors 3.3.1. B only medical providers considered as a reference point 3.3.1. B.1 Patients’ delay Considering only medical providers as a reference point, we estimated the patients’ delay. Accordingly our finding showed that the median delay from onset of cough to first visit to a medical provider was 30 days, mean 61days and IQR 15-90 days. Figure 6 shows the cumulative distribution of patients’ first visits to medical providers. As can be seen from the graph, 52% of the cases had consulted a medical provider by 1 month and for 5% of the cases, it took them more than 6 months. The longest delay was reported to be 2 years. Figure 6 Cumulative distribution of patients’ delay among smear positive pulmonary TB patient in Amhara region 120% 95% % of subjects 100% 81% 80% 69% 60% 40% 100% 52% Cummulative 32% 20% 0% 2 w eeks 1 month 2 month 3 month Duration in months 6 month above 6 month Group differences for significant patients’ delay were assessed taking a onemonth cut-off point for comparison (table 11). There were no significant differences by sex, marital status and income of the respondents. However, significant differences were observed among other variables. The median patients’ delay for those who were illiterates was 60 days compared to 30 days in those who were literates (Kruskal-Wallis test; P<0.001) The median patient’ delay varied also with age. The age group 15-24 had shorter delay compared to the older age group (> 45 years old) (Kruskal-Wallis test; P=0.007). We have also observed that the median patients’ delay varied with the patients’ area of residence. Those who lived within 10 Km radius of a medical facility reported earlier compared to those living beyond 10 Km. The durations were 25 and 70 days, respectively (Mann-Whitney test; P<0.001) (figure 7). Figure 7 Cumulative distribution of patient’s delay in relation to place of residence among smear-positive pulmonary TB patients in Amhara region. 120 % 99,50 % 100 % 89,40 % 82,90 % 80 % 69 % 60 % 42,10 % 100 % 89,90 % total 69,90 % Above 10 km 52 % 40 % Less than 10 km 49,40 % 32 % 20 % 81 % 66,20 % 95 % 33,30 % 19 % 0% 2 w eeks 1 month 2 months 3 months 6 months > 6 months P < .001 Patients that initially visited non-formal health care providers and those that treated themselves at home had also longer median patients’ delay compared to those who did not take any action prior to visiting the first medical provider (Mann-Whitney test; P<0.001). The occupational statuses of the subjects had also an effect on the median patients’ delay. Longer median patients’ delay was observed among farmers, the unemployed and housewives compared to the students, civil servants and self-employed (Kruskal-Wallis test; P=0.003). Knowledge about the symptoms and treatment of TB was found to have an effect on the median patients’ delay. Those categorized as having a higher knowledge of TB reported in 30 days compared with 60 days for those categorized as having lower knowledge (Mann Whitney test; P<0.001) (table 11). Logistic regression analysis was performed to look for the possible associations of the different variables with significant patients’ delay (Table 12). Those who lived beyond 10 Km radius of a medical facility (ORadj= 3.81, 95%CI 2.21-6.57), age>45 years (ORadj=2.62, 95% CI 1.13-6.02) and self-treatment (ORadj=1.69, 95% CI 1.04-2.75) were significantly associated with increased patients’ delay. We have also observed that the risk of patients’ delay among those who did not visit non-formal health provider prior to visiting medical provider was smaller (ORadj=0.34 95%CI 0.20, 0.57) In univariat analysis those with education above 9 th grade (COR=0.30, 95%CI 0.17, 0.53), civil servants (COR=0.42 95%CI 0.22, 0.82), and students (COR=0.35, 95%CI 0.16, 0.79) seem to have a lower risk of patients delay. However, when we tried to find out the most influential factors of patients’ delay using logistic regression analysis, these tendencies lost significance (Table 12). Table 11 Sub-group analysis showing median patients’ delay among smear positive pulmonary TB patients in Amhara region ______________________________________________________________________________ Median P-value Characteristics No patients’ delay (IQR) in days ________________________________________________________________________________ Total n=384 Sex Male 202 30 (15-90) Female 182 35 (15-90) 0.27 Age 15-24 127 30 (15-60) 24-44 216 35 (15-90) 0.007 >45 41 60 (60-120) Marital status Single 134 30 (14-90) Divorced 89 35 (15-75) Married 140 42 (15-115) 0.08 Widowed 21 30 (14-60) Education Illiterate 157 60 (15-120) < 8th grade 145 30 (30-75) 9th and above 82 22 (12-47) <0.001 Occupation Farmers 104 50 (15-90) Housewives 86 35 (15-90) Civil servants 59 30 (30-60) 0.003 Students 35 21 (15-45) Unemployed 55 55 (15-75) Self-employed 45 30 (12-60) Distance > 10Km 168 70 (12-120) 10Km 216 25 (14-60) < 0.001 Self-treatment Yes 180 45 (15-90) 0.004 No 204 30 (15-75) Health provider visit Non formal Formal Knowledge of TB Low High Income No income Irregular income Regular income 1-300 Birr > 301Birr Haemoptysis Yes No 237 147 55 (15-100) 21 (14-60) <0.001 160 224 60 (20-120) 30 (14-60) <0.001 185 114 36 42 (15-90) 30 (15-90) 21 (14-60) 30 (15-60) 0.16 49 96 288 67 (18-120) 30 (15-71) <0.001 Table 12 The associations of socio-demographic and health service factors with delay to first visit to a medical provider among smear positive pulmonary TB patients in Amhara region. Delay >31 days Characteristics Sex Male 91 Female 94 Age 15-24 49 25-44 110 >45 26 Residence >10Km 112 10Km 73 Occupation Farmers 59 Housewives 44 Civil servants 21 Students 11 Unemployed 32 Self employed 18 Marriage Single 59 Divorced 45 Married 74 Widowed 7 Education Illiterate 91 1-8th grade 70 9th and above 24 Health provider visit No delay Crude ≤30 days OR (95%CI) Adjusted OR (95% CI) 111 88 1:00 1.19 (0.80, 1.79) 1.00 1.01 (0.62, 1.91) 78 106 15 1:00 1.65 (1.08, 2.58) * 2.76 (1.33, 5.72) * 1:00 1.47 (0.86, 2.49) 2.62 (1.13, 6.09) * 56 14 3.92 (2.56, 6.00) * 1:00 3.81 (2.21, 6.57) * 1:00 45 42 38 24 23 27 1:00 0.79 (0.45, 1.42) 0.42 (0.22, 0.82) * 0.35 (0.16, 0.79) * 1.06 (0.55, 2.06) 0.51 (0.25, 1.03) 1:00 1.36 (0.12, 1.03) 0.61 (0, 17.2.19) 0.40 (0.12, 1.32) 0.96 (0.35, 2.66) 0.78 (0.26, 2.34) 75 44 66 14 1:00 1.30 (0.76, 2.22) 1.43 (0.89, 2.29) 0.64 (0.24, 1.68) 1:00 1.39 (0.72, 2.67) 1.30 (0.69, 2.42) 0.69 (0.22, 2.16) 66 75 58 1:00 0.68 (0.43, 1.07) 0.30 (0.17, 0.53) * 1:00 1.38 (0.67, 2.83) 1.47 (0.75, 2.87) Formal 47 100 1:00 1:00 Non formal 138 99 2.97 (1.93, 4.57) * 0.34 (0.20, 0.57) * Income No income 100 85 1:00 1:00 Irregular income 54 60 0.77 (0.48, 1.22) 1.30 (0.43, 3.90) 1-300 Birr 14 22 0.54 (0.26, 1.12) 0.57 (0.16, 1.98) >301birr 17 32 0.45 (0.23, 1.87) 0.49 (0.17, 1.46) Self-treatment Yes 121 59 1.75 (1.16, 2.62) * 1.69 (1.04, 2.75) * No 110 94 1:00 1:00 Knowledge of TB Low 100 60 2.72 (1.79, 4.14) * 1.89 (1.15, 3.10) * High 85 139 1:00 1:00 Stigma Low 67 66 1:00 1:00 High 118 133 0.87 (0.57, 1.33) 0.88 (0.54, 1.45) ___________________________________________________________________________ * Significant at <0.05 ** Adjusted for socio-demographic and health service factors 3.3.1. B.2 Medical providers’ delay The median delay from first visit to a medical provider to first reporting to a TBMU was 15 days, mean 36 and IQR 0-53 days. The median medical providers’ delay did not vary according to some selected socio-demographic factors. However, those who first visited a health post or a private medical provider had longer delay compared to those who visited a government health center (Kruskal-wallis test; p< 0.001) (table 13). Table 13 Sub-group analysis showing median medical providers’ delay among smear positive pulmonary TB patients in Amhara region ________________________________________________________________________ Variable N Median delay (IQR) P-Value ________________________________________________________________________ Sex Male 202 57 (27-144) Female 182 65 (37-118) 0.51 Age 15-24 127 10 (10-30) 25-44 216 20 (0-60) 0.089 >45 41 30 (0-59) Education 12 Illiterate 157 15 (0-60) 1-8th 12 20 (0-56) 0.182 th >9 82 10 (0-38) Distance >10 km 168 13 (0-60) 10Km 216 21 (0-52) 0.328 Health provider Clinic/health post 59 30 (7-78) Health center 146 8 (0-40) 0.001 Hospital 50 7 (0-44) Private medical 76 32 (3-75) providers _____________________________________________________________________ In this study, subjects were found to have visited a considerable number of medical providers before ending up in the final diagnosis. The median number of medical providers seen prior to starting TB treatment was 2 (IQR1-3) and the highest was 8. This is not taking in to account the number of visits made to the same medical providers. For 86 (22.5%) of the subjects, the total number of medical provider seen exceeded 4 (figure 8). We compared the frequency of medical providers visit prior to the diagnosis of TB with the socio-demographic factors. There was no effect of sex, age, area of residence, education, income or occupation on the number of medical providers seen (Table 14). Figure 8 Graph showing the frequency of medical providers’ visit prior to the diagnosis of TB among smear positive pulmonary TB patients in Amhara region, September-December 2003. 140 Frequency 120 100 80 60 40 20 0 0 1 2 3 4 5 6 7 8 Number of visits Table 14 Comparisons of the socio-demographic factors with the frequency of medical providers visit prior to the diagnosis of TB among smear positive pulmonary TB patients in Amhara region. _______________________________________________________________________ Variable N Median number of (IQR) P-Value of providers ________________________________________________________________________ Sex Male Female 202 182 2 (1-3) 2 (1-3) 127 216 41 2 (1-3) 2 (1-3) 2 (2-4) 157 12 2 (1-3) 2 (1-3) 0.16* Age 15-24 25-44 >45 Education Illiterate 1-8th 0.10* 0.95* >9th 82 2 (1-3) Distance >10 km 168 2 (1-3) 10Km 216 2 (1-4) 0.53* Monthly income (Birr) No income 170 2 (1-4) Irregular income 104 2 (1-3) 0.25* * Income1-300 Birr 59 2 (2-3) Income >301 Birr 51 2 (1-3) Occupation Farmers 104 2 (1-3) House wife 86 2 (1-3) 0.51** Civil servants 59 2 (2-4) Students 35 2 (1-4) Unemployed 55 2 (1-3) Self-employed 45 2 (1-3) _____________________________________________________________________ *Mann-Whitney test **Kruskal Wallis test The cumulative distribution of the median medical providers’ delay is presented in figure (9). Forty percent of the respondents had a median medical providers’ delay of 7 days. However, for 20 % of the cases the medical providers’ delay was more than 3 months prior to reporting to a TBMU. These were more likely to be living more than 10Km 32/168vs 20/216, P= 0.009 to have visited health post 18/77 vs 34/273, P=0.006 and to be illiterate 29/157vs 4/82, P=0.014 (table 15). Figure 9 Cumulative distribution of medical provider delay among smear-positive pulmonary TB patients in Amhara region 100 % 80 % 80 % 52 % 60 % 40 % 20 % 40 % 62 % Table 15 Comparisons of medical providers’ delay in those who reported within 3 and above 3 months with some socio-demographic factor among smear positive pulmonary patients in Amhara region. ______________________________________________________________________________ _ Duration of illness Variable 90 days >91 days P- value Sex Male 177 25 0.58 Female 155 27 Age 15-24 115 12 25-44 182 34 0.253 >45 35 6 Education Illiterate 128 29 1-8th grade 126 19 0.014 > 9th grade 78 4 Income No income 163 22 Irregular income 94 20 0.32 Regular income 1-300 Birr 30 6 Regular income >301 Birr 45 4 Distance >10 Km 136 32 0.009 10Km 196 20 Medical provider Health post 59 18 Health center 146 17 0.006 Hospital 50 2 Private 77 15 ___________________________________________________________________________ 3.3.1. B.3 Health systems’ delay The median health systems’ delay was 21 days, mean 42 days IQR being 7-60 days. The cumulative distribution of health systems’ delay is presented in figure 10. From the graph we can see that from the time the subjects first visited a medical facility, 42.2% started treatment within 2 weeks and for 24% of the subjects, the median health systems’ delay was more than 2 months. These were more likely to be living at a distance of more than 10 Km away from a medical facility, to be illiterates and to be above the age of 25 years (table 16). Figure 10 Cumulative distribution of health system’ delay among smear-positive pulmonary TB patients in Amhara region. 120% 100% 93% 97% 100% 80% 76% 60% 40% 65% 42% 20% 0% 2 w eeks 1 month 2 months 3 months 6 months > 6 months Table 16 Selected socio-demographic factors associated with delay for more than three months before commencing anti-TB chemotherapy among smear positive pulmonary TB patients in Amhara region. ________________________________________________________________________ Duration of illness Characteristics 120 days >121 days OR (95% CI) ________________________________________________________________________ Sex Male 143 59 1:00 Female 120 62 1.25 (0.81, 1.92) Age 15-24 102 25 1:00 25-44 139 77 2.26 (1.35, 3.79) * > 45 22 19 3.50 (1.65, 7.48) * Education Illiterate 85 72 1:00 1- 8th grade 104 41 0.46 (0.28, 0.78) * th > 9 grade 74 8 0.12 (0.58, 0.28) * Residence >10 Km 93 75 1:00 10 Km 170 46 0.33 (0.21, 0.52) * Income No income 120 65 Irregular income 79 35 0.81 (0.49, 1.39) Regular income 25 11 0.81 (0.37, 1.76) 1-300 Regular income 39 10 47 (0.22, 1.00) > 301 ________________________________________________________________________ * Significant at point < 0.05 Comparison among the various groups of respondents was made to look for differences with regards to health systems’ delay (table 17). Significant differences were not observed for most socio-demographic factors. But the median health systems’ delay among the age group 15-24 was 14 days compared to 27 days among the age group 25 and above years (Kruskal-Wallis test; P=0.028) and those that visited private medical providers first had a longer health systems’ delay compared to those that visited government medical providers (P=0.022). The median health systems’ delay for those who went to a health post was 39 days compared to 14 days in those that went to a health center or hospital (Kruskal-Wallis test; P<0.001). In logistics regression analysis, those who first visited a health post (ORadj= 3.50, 95% CI 1.86-6.57) or a private medical provider (ORadj=2.10 95% 1.18, 3.71) were significantly associated with increased health systems’ delay (Table 18). Table 17 Sub-group analysis showing median health systems’ delay among smear positive pulmonary TB patients in Amhara region ___________________________________________________________________________ Median health systems’ P-value Characteristics NO Delay (IQR), in days ___________________________________________________________________________ Total n=384 Sex Male 202 20 (7-60) Female 182 22 (8-60) 0.59 Age 15-24 127 14 (6-43) 24-44 216 27 (8-43) 0.028 >45 41 27 (7-64) Marital status Single 134 24 (24-60) Divorced 89 20 (20-50) Married 140 21 (21-75) 0.79 Widowed 21 35 (5-58) Education Illiterate 157 22 (8-69) < 8th grade 145 22 (7-61) 9th and above 82 20 (7-46) 0.31 Occupation Farmers 104 19 (16-65) Housewives 86 36 (14-79) Civil-servants 59 14 (25-75) 0.12 Students 35 19 (6-37) Unemployed 55 20 (7-57) Self employed 45 21 (5-61) Income No income 170 23 (9-57) Irregular income 104 20 (7-61) 0.38 1ncome 1-300 Birr 59 36 (6-80) Income > 301 Birr 51 14 (6-53) Distance > 10Km 168 19 (7-64) 10Km 216 27 (8-58) 0.55 Health provider Visit (general) Private 92 36 (10-80) Government 292 20 (7-57) 0.022 Health provider Visit (specific) Health post 77 39 (17-85) Health center 163 14 (6-45) <0.001 Hospital 52 14 (7-48) Private 92 36 910-80 _________________________________________________________________________ Table 18 The associations of socio-demographic and health service factors with health systems’ delay among smear positive patients in Amhara region _________________________________________________________________________ Delay No delay Crude Adjusted Characteristics >16 days ≤15 days OR (95%CI) OR (95% CI) Sex Male Female Age 117 103 85 79 1:00 1:00 0.95 (0.63, 1.42) 0.73 (0.44, 1.21) 15-24 25-44 >45 Marital status 63 133 24 64 83 17 1:00 1:00 1.65(1.08, 2.58) * 1.62 (0.98, 2.61) 2.76 (1.33, 5.72* 1.30 (0.59, 2.90) Single Divorced Married Widowed Occupation Farmers Housewives Civil servants Students Unemployed Self-employed Income 79 52 76 13 55 37 64 8 1:00 0.97 (0.56, 1.68) 0.83 (0.51, 1.33) 1.13 (0.94, 2.91) 1:00 1.12 (0.61, 2.05) 0.91 (0.51, 1.64) 1.12 (0.38, 3.26) 46 26 31 17 23 21 58 60 28 18 32 24 1:00 1.80 (1.00, 3.33) 0.71 (0.37, 1.36) 0.84 (0.39, 1.80) 1.10 (0.57, 2.13) 0.90 (0.44, 1.82) 2.16 (0.84, 5.5) 0.74 (0.26, 2.17) 0.68 (0.24, 1.93) 0.92 (0.37, 2.31) 0.64 (0.24, 1.70) No income 73 112 1:00 Irregular income Income1-300birr >301 Residence >10Km 10Km Education Illiterate 1-8th grade 9th and above Medical provider 50 14 27 64 22 22 0.83 (0.52, 1.33) 0.91 (0.43, 1.94) 1.0 0(0.49, 2.13) 1.62 (0.61, 4.18) 0.53 (0.28, 1.00) 0.54 (0.19, 1.48) 90 130 78 86 1:00 1.31 (0.87, 1.97) 1:00 2.01 (1.22, 3.48) * 90 85 45 67 60 37 1:00 1.06 (0.67, 1.67) 0.90 (053, 1.55) 1:00 1.00 (0.59, 1.69) 0.64 (0.33, 1.23) Health center 79 84 1:00 1: 00 Health post 57 20 3.03 (1.67, 5.49) * 3.90 (2.06, 7.64) * Hospital 23 29 0.84 (0.45, 1.58) 0.82 (0.41, 1.62) Private 61 31 2.32 (1.23, 3.55) * 2.32 (1.23, 4.23) * _____________________________________________________________________ * Significant at 0.05 ** Adjusted for socio demographic and health service factors 3.3.1. B. 4 Diagnosing facilities’ delay Several providers referred patients to the TBMUs for diagnosis and initiation of anti-TB chemotherapy. In general, government health assistants, nurses or doctors referred 271 (70.6%) of the patients. Private medical providers referred 92 (24.0%), 11 (2.9%) were self-referred, 2 (0.5%) were referred by pharmacists and 8 (2.1%) were referred by friends. The median diagnosing facilities’ delay from reporting to the TBMU to AFB request, from AFB exam to notification and from notification to initiation of treatment was 2 days, respectively. Overall, the median diagnosing facilities’ delay was 5 days, mean, 6.7 and IQR 4-8. But for 13 patients, the median delay exceeded 15 days and the longest delay was reported to be 31 days. In this study it was observed that all patients that were referred from private doctors were required to be re-examined and submit sputum for AFB at the TBMU despite having a referral paper and clear cut diagnosis of smear positive pulmonary TB from the private medical doctor. It was also observed that the TBMU expected every smear positive patient to fulfill one major criterion before starting anti-TB chemotherapy.I.e., all patients were required to have some-body (preferably a relative) with them who had a defined address and was willing to be responsible for tracing the patient in case of default after starting treatment. This procedure was a must; otherwise, patients were not entitled to start anti -TB chemotherapy despite having a positive smear result. Among the 13 patients whose median diagnosing facilities’ delay exceeded 15 days, 10 (86.7%) were those who could not manage to bring a responsible person at the time of diagnosis. These patients went back long distances to their residence area to bring a relative and start their treatment. All patients after being diagnosed and took the first anti-TB drug on the spot at the TBMU were sent back to the nearest health care facility to their home for the continuation of the rest of the treatment. 3.3.2 Total delay In this study, the median and mean total delays were 80 and104 days, respectively. The IQR was 44.2-129.8 days. The distribution of the reported duration of symptoms prior to treatment is shown in figure 11. As can be seen from the graph, only 9% of the total respondents were detected and put on treatment within one month of the onset of their illness. For 121 (31%) of the cases, the median total delay exceeded 4 months. These patients were more likely to be older 19/41vs 102/343, (P<0.001), to live in a distance of more than 10 km away from a medical facility, 75/168 vs 46/216, (P<0.001) not to have gone to school 72/157 vs 49/227, (P<0.005). Figure 11 Cumulative distribution of total delay among smear-positive pulmonary TB patients in Amhara region, August to December 2003 120 % In this study, the median (IQR) total delay to treatment varied with the subjects’ area of residence. For those who live 10 Km away from a medical health provider, the length of delay was 100 days (IQR 65-191 days) but for those that live within 10 Km radius of a formal health care facility, the median delay was shorter 65days (IQR 36-98days) (Mann-Whitney test; P<0.001) (table 19). The subjects’ occupation appeared to influence the median total delay. Those who reported shorter delay include self-employed 67 days (IQR, 38-112days), civil servants 65 days (IQR, 35-98days) and students 51days (35-69days). Where as longer delays were reported among housewives, 98 days (IQR, 65-172 days), farmers 97 days (IQR, 61, 188 days) and by the unemployed 78 days (IQR, 45-155 days). It also varied with the patients’ educational level. Illiterates had a median total delay of 98 days (IQR 65-186 days) and those with education above the level of 9th grade, the median total delay was shorter, 48 days (IQR 34-83 days) (Kruskal-Wallis test; P=0.005). The subjects’ marital status was found to affect the median total delay. Married subjects were found to have the longest delay, 97days (IQR 62-172days) compared to those who were never married, 67 days (IQR 36-126 days) (Kruskal-Wallis test; P=0.019). Age also had an effect on the median total delay. Those who were between 25 and 44 had longer delay compared to those below 24 years of age (P=0.016). Patients who treated themselves at the onset of the initial symptoms at their home had a longer total delay compared to those that did not try self-treatment. The median total delay was 95 days (IQR 65-185 days) vs 65 days (IQR 36123days) (Mann-Whitney test; P=0.005). Also, patients with haemoptysis had longer duration of total delay than those with out haemoptysis (median 125 vs 67days Mann-Whitney test; P=0.005) Table 20 shows the association of socio-demographic and health services factors with the median total delay. Accordingly the age group 25-44 (ORadj=1.85, 95%CI 1.06, 3.20) was significantly related with increased total delay compared to the age group 15-24years. Marital and educational statuses of the study groups were associated with increased total delay. The married group had increased risk of delay compared to the singles (ORadj= 2.26 95% CI 1.14, 4.10) and those with education above the level of 9 th grade had a smaller risk of total delay compared to the illiterates (ORadj= 0.42 95%CI 0.19, 0.89). Besides these, those who first treated themselves (ORadj=1.75, 95%CI 1.05, 2.93) and those who went to the non-formal health providers (ORadj =2.52 95%CI 1.49, 4.23) were characterized as having a higher risk of longer median total delay. Regarding the knowledge of patients about TB, it was found that those with low level of knowledge (ORadj=3.49 95% CI 2.01, 5.80) had a 3-fold risk of total delay than those having lower level of knowledge about TB. In univariat analysis age >45 years (ORadj=1.67 95%CI, 0.72, 3.80), civil servants (OR=0.39, 95%CI 0.20, 0.76), students (OR=0.21, 95%CI 0.87, 0.50) and self-employed (OR=047, 95%CI 0.23, 0.96) seem to have a smaller risk of delay compared to the farmers. But when we analyzed the possible effects of the interaction of the entire variables using multi-variat (logistic regression) analysis, these tendencies lost significance. Table 19 Sub-group analysis showing median total delay among smear positive pulmonary TB patients in Amhara region ___________________________________________________________________________ Median total Characters tics No Delay (IQR) P-value ___________________________________________________________________________ Total n=384 Sex Male 202 69 (38-125) Female 182 93 (61-150) 0.095 Age 15-24 49 64 (35-100) 25-44 278 94 (62-147) 0.016 >45 57 95 (97-194) Marital status Single 127 67 (36-126) Divorced 79 69 (39-124) Married 164 97(62-172) <0.001 Widowed 14 67(63-95) Education Illiterate 157 98 (65-186) < 8th grade 145 69 (48-126) <0.001 9th and above 82 48 (34-83) Occupation Farmer 104 97 (61-188) Housewife 86 98 (65-172) Civil servant 59 65 (35-98) Student 35 51 (35-69) <0.001 Unemployed 55 78 (45-155) Self-employed 45 67 (38-112) Distance > 10Km 168 100 (65-191) 10Km 216 65 (36- 98) <0.001 Self-treatment Yes 180 95 (65-185) No 204 69 (36-123) <0.001 Income range No income 185 93 (50-159) Irregular Income 114 84 (49-134 1-300 Birr 36 91 (45-126) 0.032 > 301Birr 49 49 (65-149) Med pro visit Private 92 68 (35-123) 0.078 Government 292 91 (49-149) Health pro visit Non formal 147 96 (64-184) <0.001 Formal 237 64 (35-96) Haemoptysis Yes 96 110 (83-185) No 288 67 (38-123) <0.001 Knowledge Low 160 112 (66-188) High 224 65 (36- 96) <0.001 _____________________________________________________________________________ Table 20 The relationships of socio-demographic and health service factors with late initiation of anti TB chemotherapy among smear positive pulmonary TB patients in Amhara region. ______________________________________________________________________ Delay No delay Crude Adjusted Variable > 81 days ≤80 days OR (95% CI) OR (95% CI) _______________________________________________________________________ Sex Male 91 111 1:00 1:00 Female 83 99 1.33 (0.89, 1.99) 0.81 (0.48, 1.36) Age 15-24 49 78 1:00 1:00 25-44 118 98 1.92 (1.23, 2.99) * 1.85 (1.06, 3.20) * >45 23 18 2.03 (0.99, 4.44) 1.67 (0.72, 3.80) Marital status Single 57 77 1:00 1:00 Divorced 38 51 1.01 (0.58, 1.73) 1.02 (0.52, 1.92) Married 89 51 2.36 (1.45, 3.83) * 2.18 (1.14, 4.19) * Widowed 6 15 0.54 (0.19, 1.48) 0.47 (0.14, 1.55) Occupation Farmers 61 43 1:00 1:00 House wife 55 31 1.25 (0.69, 2.25) 0.84 (0.24, 1.93) Civil servants 21 38 0.39 (0.20, 0.75) * 0.45 (0.12, 1.60) Students 8 27 0.21 (0.87, 0.50) * 0.28 (0.07, 1.01) Unemployed 27 28 0.68 (0.35, 1.31) 0.69 (0.25, 1.93) Self employed 18 27 0.47 (0.23, 0.96) * 0.46 (0.15, 1.46) Education Illiterate 104 53 1:00 1:00 1-8grade completed 66 79 0.43 (0.27, 0.68) * 0.65 (0.37, 1.16) 9th grade and above 20 62 0.16 (0.09, 0.30) * 0.42 (0.19, 0.89) * Income No income 103 82 1:00 1:00 Irregular income 62 52 0.89 (0.56, 1.42) 0.68(0.27, 1.65) Income 1-300 Birr 19 17 0.99 (0.49, 2.02) 1.48 (0.52, 4.19) Income >301Birr 6 43 0.43 (0.22, 0.84) * 0.93 (0.29, 2.91) Distance >10km 109 59 3.0 (2.0, 4.7) * 1.80 (1.02, 3.17) * <10Km 81 135 1:00 1:00 First health pro visit Non formal 134 103 3.08 (2.02, 4.68) * 2.52 (1.49, 4.23) * Formal 56 91 1: 00 Self-treatment Yes 103 77 1.80 (1.2, 2.7) * 1.75 (1.05, 2.93) * No 87 117 1: 00 1:00 Knowledge of TB Low 114 46 4.80(3.1, 7.49) * 3.49 (2.01. 5.80) * High 76 148 1:00 1:00 Stigma High 70 63 1:00 1:00 Low 120 131 0.82 (0.54, 1.25) 0.81 (0.48, 1.36) ______________________________________________________________________________ * Significant at 0.05 ** Adjusted for socio demographic and health service factors In general, taking all health providers and only medical providers as a reference point separately, we can see variations in the length of the different delay periods. In the first scenario (figure12) patients who first visited a medical provider had a median delay of 30 days. In the second scenario (figure 14) considering all health providers as potential venues of health seeking, we can see that patients visit a health provider relatively early compared to the first scenario. The health-seeking period is shorter. It took them only 15 days to first visit a health provider. Overall the contribution of the health-seeking period by patients to the total delay is smaller. As shown in figure 14, the greater portion (81%) of the delay was due to the health provider. Figure 12 Graph showing the median delay periods taking only medical providers as a reference point among smear positive pulmonary TB patients in Amhara region. 90 80 80 median in days 70 60 50 40 30 30 21 20 10 0 Patients’ delay Health systems’delay Total delay Figure 13 Graph showing the median delay periods taking all health providers as a reference point among smear positive pulmonary TB patients in Amhara region. 90 80 80 median in days 70 62 60 50 40 30 20 15 5 10 0 Health seeking period Health providers’ delay Diagnosing facility delay Total delay Figure 14 Pie chart showing the contribution of health seeking period and health providers’ delay to the total delay among smear positive pulmonary TB cases in Amhara region 18.70% 81.30% Health seeking period Health providers’ delay Finally, as a summary we have presented a diagram showing the different delay periods starting from onset of cough until the patient is put on anti-TB chemotherapy. It also shows the patients’ possible choices of health providers. (See figure 15) 3.4 TB diagnosis at the private medical providers In this study, it was found that 92 (24%) of the total study subjects were diagnosed and referred to the TBMU for treatment by private medical providers. According to the national TB control program guideline of Ethiopia, all smear positive pulmonary cases diagnosed at the private medical providers must be referred to the government TBMU for initiation of chemotherapy. But in this study, it was found that 14 (15.2%) of the subjects after being diagnosed at the private doctors had prescriptions of anti-TB drugs. These patients directly started anti-TB chemotherapy by purchasing drugs at the private pharmacies. During the interview the subjects reported that, they took anti-TB drugs for 1-2 month. The reason that they came to the TBMU was that the pharmacies had run out of drugs. 3.5 Stigma TB was found to be stigmatized among the respondents. Two hundred eighty five (75%) believed that TB is a social stigma and 270 (70%) responded that they would not enter others social circle for fear of not being accepted by others. Subjects also closely linked TB and HIV. Two hundred and five (53.4%) of the respondents said that TB is associated with HIV and of these, 179 (47%) believed that going to a medical provider for TB test can make other people think that the person has AIDS. Forty-eight (12.5%) said that they had a fear of being tested for HIV when they initially reported to the medical provider. However, we did not find associations between stigmatizing attitudes to wards TB/HIV and patients’ delay. Chapter four: Discussion 4.1 The distribution of the sample population In our study, the distribution of the study population by sex showed that the proportion of males exceeds that of the females. This is quite similar with the notification trend at national and regional levels (11). It is also similar with the global trend. According to Rieder (1999) in virtually all countries, notification rates among males are higher than among females (34). The distribution of the population by age also showed that the majority was in the productive age group. The mean age in the study population was 29 years. This is also similar with the trend in general in developing countries. In developing countries, TB peaks in young adults and it is estimated that 75% of the TB cases notified are in their productive age group (71). The higher proportion of the Amhara ethnic group and Christians in the sample population follows the general pattern of population distribution for the region (12). In this study, 40.9% of our sample population were illiterate (especially females being more illiterate), had no defined income and were sharing a single room with an average family size of five. This clearly indicates a very poor socioeconomic condition among the study population. As Rieder (1999) described it, TB and poverty are strongly associated and low socio-economic indicators tend to result in conditions that are conducive to increased transmission of tubercle bacilli, resulting thus in a generally higher prevalence of TB infection with subsequent increased incidence of the disease. According to the World Bank classification, 78% of the 22 countries with the highest TB burden in the world are low-income countries and it is known that Ethiopia is in this group (13). In general, the current TB situation in this sample population clearly confirms the fact that TB is a disease of lower income and lower resource countries. 4.2.1 The health seeking period and health providers’ delay In this study, we were very much surprised to observe that many of our subjects visited the health providers to seek for health care quite early. The delay period from onset of major symptoms to first visit to a health provider was only 15 days. This is in fact the same as the result documented in the Gambian study (19), which clearly indicates that, patients seek health care early but the type of health providers they visit varies considerably. On the other hand, 81% of the delay was attributed to the health providers. The median health providers’ delay was 61 days. This is higher than the result reported in the Gambia (19). The long health providers’ delay in our study might be related to the fact that the majority, 61.7%, of the subjects initially went to the non-formal health providers to seek for health care, in which case the likelihood of being referred to the formal health providers for diagnosis might be less. As a result, patients might spend longer time before they get the correct diagnosis. The logistic regression analysis performed to analyze the possible association of the factors between the socio-demographic factors and the median health providers’ delay showed that the literates in general, those who lived within 10 Km radius of a medical facility and those who had visited the formal health providers initially had lower risk of increased health providers’ delay. This might be related to the fact that being literate, subjects might have better knowledge of TB so that they might frequently visit health providers till they get diagnosed. Residing within 10 Km radius of a medical facility is also an advantage to seek for health care and of course visiting a medical provider initially might help to get the diagnosis in a relatively shorter period of time than visiting the non-formal health providers. On the other hand, those who were between 25-44 years of age had experienced longer health providers’ delay. The reasons might be related to the fact that these are within the productive age group. They are the working force in the community. Much of their time is usually allocated for work. As a result they might fail to give priority for health care during their illness. They might also choose the shortest option i.e. buying drugs from the drug retail outlets to save time. This is also evidenced in this study by 31% of the respondents primarily visiting the drug retail outlets at the onset of the present illness. 4.2.2 Patients’ delay Taking only medical providers as a reference point, we found a median patients’ delay of 30 days. This finding is similar with other studies that were conducted in Botswana (18), Ghana (16), Philippines (73) and Penang (74) that showed a median patients’ delay of 3 - 4 weeks. On the other hand, our finding is much lower compared to the previous two Ethiopian studies that showed median patients’ delay of 179 and 60 days, respectively (22, 23). The reasons for our relatively shorter patients’ delay compared to the previous Ethiopian studies might be related to the fact that we considered all levels of health care including the lowest health care facilities (clinics & health posts) as relevant sites for first health seeking contact for our study subjects. This may have shortened the patients’ delay, as health posts and clinics are relatively closer to the community compared to the health centers and hospital, which are concentrated in major towns. Health centers and hospitals are diagnosing facilities in the region. The previous two Ethiopian studies considered subjects coming to these facilities only. This relatively short patients’ delay may also further be explained by the fact that currently there is a rapid change of health care system in the country, where there is an increase in the participation of the private sector and expansion of the health service to the population (11). As a result of these facts, patients might have a better access to health care than before. Hence this may have resulted in a short duration of patients’ delay. Therefore, we should not be surprised at observing longer patients’ delay in the two previous Ethiopian studies that considered health centers and hospitals as the lowest level of health care contact for patients, in which case, the likelihood of presenting late may be very high. Because, these facilities were inaccessible for the majority of the population in the previous times when the studies were conducted On the other hand, even though our median patients’ delay seemed to be shorter, 48% of the subjects were delayed for more than 30 days prior to presenting to a medical provider. This delay was significantly associated with older age and distance from a health care facility. These have proved to be also important factors in other studies that were conducted in Zambia (48) and south Ethiopia (22). In our case, the reasons might be related to the fact that old people are usually dependent on other persons which makes it difficult for them to visit health facilities early. There is also generally poor access to health care for the regions’ population. Low level of knowledge about the symptom and treatment of TB was associated with patients’ delay. This is in accordance with the previous study done in Ethiopia (23), Vietnam (58) and Tanzania (50). Patients who presented with haemoptysis had also a longer patients’ delay. In this regard, similar observation was made in south Ethiopia (22), which suggests that patients stay at home until they observe an alarming symptom like haemoptysis. We observed a significant association between self-treatment at home and longer patients’ delay. Studies conducted in other African countries such as Ghana (16), Botswana (18) and Kenya (53) also showed the same result. Selftreatment was also found to be a common practice in the previous unpublished Ethiopian study (57). Patients usually start treating themselves with homemade remedies during their early symptoms. It is when the symptoms get worse that they start seeking help from medical providers. This may be related to poor knowledge of TB symptoms and its treatment among the population. It may also be related to poor access of medical care to the general population. In the present study, we did not find an association between educational status and patients’ delay and between occupational statuses and patients’ delay. However, the study from south Ethiopia has documented that being illiterate, a house wife and a farmer were associated with longer patients’ delay (22). In our study, even though these factors seemed to be associated in the univariat analysis, their effect disappeared in the multivariate (logistic regression analysis). This indicates that education and occupational statuses did not turn out to be potential predictors of patient’ delay. Other studies have documented that females took longer time to seek for health care compared to males (16, 58). This finding could not be confirmed in our study. In our case, the presence of integrated health service at all levels of health care that gives more emphasis to women and children, the continuous campaigns on polio, measles and tetanus immunizations might have helped the women to appreciate the benefit of medical care. Mothers usually visit health care facilities for ante-natal care, family panning and for immunization service for their children. During these times they attend health education sessions in health institutions. This might have an effect on their health seeking behavior. It seems also that women in our case do not have decision making problem for seeking health care. As indicated in the results section, 85% of the married subjects claimed that they could decide on their own about where to go for help during their illness. Therefore, all these reasons in our case might have helped the women to seek for health to the same extent as men. TB and HIV seem to be closely linked in the peoples’ mind in Ethiopia. The current study showed that 47% of the subjects believed that TB and HIV are associated and said that, coming to a health care facility for TB symptoms can make other people think that the person has AIDS. Other Studies in this regard have shown that, there is discrimination that surrounds HIV and TB patients that may prevent them from seeking health care by going to public health care facilities (64). However, the current study was not able to demonstrate a significant relationship between those who expressed their feeling about the stigmatizing attitudes towards TB and HIV and delay to coming to medical providers. This might be related to lack of openness among the subjects in expressing their genuine feeling about stigmatizing attitudes during the interviews or it might also be a true finding. 4.2.3 Health systems’ delay With regard to the health systems’ delay, our result showed a median delay of 21 days. This is more or less similar with other studies conducted in Tanzania (46), Penang (74), New York (47) and Japan (75) that showed a median health services delay of 3 weeks to 1 month. On the other hand, a relatively shorter health service delay of 6 days was observed in the previous Ethiopian study (23). Our result shows a longer delay compared to this study. This may be related to the study setting in which case the previous Ethiopian study (23) included subjects who presented initially to a diagnosing facility, which makes it of course shorter as these patient can be evaluated and diagnosed on the spot. Whereas our study population included patients that were referred from clinics, health posts and private medical providers without diagnostic facilities. This might make the period of diagnosis and commencement of treatment longer as it takes considerable period of time to reach the TBMU from the time of referral. In this study, prior attendance to a health post/clinic was a risk factor for longer health systems’ delay. Similar finding was observed in Botswana (18). Our finding may be explained by the fact that, health posts and clinics are run by health assistants and junior nurses whose primary training is not to diagnose serious diseases but to concentrate on patient care and preventive activities. Besides this, these facilities are not equipped with the necessary diagnostic equipments like microscopes and others. As a result, subjects might be misdiagnosed and mismanaged. This might cause prolonged delay before diagnosis. Prior attendance to non-formal health providers was also significantly associated with longer health systems’ delay. This finding is a little higher than the results documented in the study done in Dabat district in Northwest Ethiopia (76). The common reasons for not visiting formal health providers in our study were that, illness was considered harmless followed by health institution being very far from home and the feeling that self-treatment was sufficient. These responses could be related to several issues including lack of knowledge of symptoms of TB, the perception of the relatives on how long after the onset of an illness it is proper for a patient to still go to health institutions, lack of confidence in modern health care and poor access to medical providers. In the current study, those who visited private medical providers had longer health systems’ delay. Similar finding was observed in Penang (74), where patients who first consulted a private practitioner were the least likely to be diagnosed appropriately. The reason for long health systems’ delay in our case might be related to the guideline of the TB control program of the Regional Health Bureau that strictly forbids the private medical providers to treat TB cases. According to the guideline (12), patients diagnosed as having smear positive pulmonary TB must be referred to the government TBMU for the initiation of antiTB chemotherapy. Patients will be re-examined and sputum for AFB will be requested for the second time at the TBMU. Therefore, there is no doubt that all these procedure might take additional time for patients who visited the private medical providers prior to diagnosis and starting treatment compared to other patients that directly went to the TBMU. Apart from the above significant risk factors, we did not find associations between socio-demographic factors and longer health systems’ delays. This finding is similar with other studies conducted in countries like Zambia (64), Botswana (18) and Penang (74) but different from Ghana (16) where women and rural residents had longer health systems’ delay and a previous Ethiopian study (23) in which distance to health care facility was found to be a risk factor. With regard to medical providers’ delay, long distance to the TBMU, being illiterate and prior attendance to a health post were risk factors for being delayed for more than 3 months in some of our respondents. This may be related to the fact that diagnosing facilities are found in major towns. Therefore, for those living in rural areas these facilities might not be easily accessible, as a result, these patients might delay longer before reaching diagnosing facilities. Patients who are illiterate might not also go to the higher level even though they are referred. They might not take the referral seriously. Because the general knowledge about the consequences of late presentation might be low. Therefore, they might not be motivated to go to the next level of health care earlier compared to the literates. With regard to the relation between prior visits to health posts and medical providers’ delay, it might be explained by the fact that, health posts are not well equipped with well-qualified health professionals and equipment to diagnose TB compared to health centers and hospitals. Therefore, patients might be misdiagnosed or mismanaged resulting in longer delays. 4.2.4 Diagnosing facilities’ delay As for the diagnosing facility’s delay, the present study showed a median diagnosing facilities’ delay of 5 days. This is a little bit higher than the Gambian study that showed a median diagnosing facilities’ delay of 0.2 weeks (22). This may be because of the fact that the Gambia is a small densely populated country with 87% of the population having a good access to health care within a 3 Km radius (19), unlike Ethiopia where the health service coverage is not beyond 50% (3). But still, we have a feeling that, the diagnosing facilities’ delay observed in this study is not that wide. We would say that patients get their diagnosis and commence their treatment within a reasonable period of time as long as they manage to reach the TBMU. Patients in this study were shopping for treatment for a considerable period of time prior to diagnosis. The average (mean) number of medical providers visited was two. This is excluding repeated visits made to the same providers. Our finding is different from the Gambia where patients visited 4 medical providers prior to diagnosis. This might show that our patients are referred earlier to the TBMU or patients might not frequently shop for treatment from different medical providers, as the numbers of private providers are relatively small compared to the Gambian study, or patients might stick all the time to the first private medical provider till diagnosis or referral. 4.2.5 Total delay The median total delay observed in this study was 80 days. This is different from the previous south Ethiopian study (22) that showed a median total delay of four months. However, a more or less similar finding was observed in other countries like Gambia (19) Botswana (18), and Penang (74) that showed a median total delay of 8.6 and 12 weeks, respectively. The reason for our relatively shorter total delay compared to the previous south Ethiopian study may be related to the increase in DOTS coverage in the region. Currently, 51% of the region has been covered by DOTS unlike the previous years where DOTS coverage was very low (12). The risk of increased total delay was also higher in those with education less than 9th grade and in married couples compared to those above 9 th grade and the singles, respectively. In this regard, similar finding was observed in the previous south Ethiopian study (19) and may be explained by the fact that subjects with lower level of education might have poor awareness regarding the symptoms and treatment of TB and married couples might have shortage of time to care or give attention for themselves, as they are usually responsible for the entire family. In this study, far distance to patients’ home and low-level knowledge about the symptoms and treatment of TB were also associated with increased median total delay. This result is consistent with the findings in Botswana (18), southern Ethiopia (22) and Vietnam (58). As has been described in the results section, the majority (57 %), of the patients at the onset of their illness related their symptoms to other diseases. Moreover, most of the study subjects believed that, the symptoms would disappear by themselves. This clearly shows a lack of knowledge among our study subjects with perceptions and practices that might delay the patient. Therefore, we were not surprised to observe this significant association in our study. The same might be true for the association observed between self-treatment and increased total delay. In general, we have seen from the above discussion that delay in diagnosis has been studied in many countries. In all of these studies, a range of conflicting differences on the lengths and risk factors of diagnostic delays have been documented. Likewise, the present study showed similarities and differences in the choice of first health providers, and in the lengths and risk factors of the different delays when compared to other studies. This may due to various factors related to the study setting, the method of estimating the time from onset of symptoms to seeking medical care and the characteristics of the study population under which our study was conducted. With regard to the choice of first health provider, in almost all the previous studies reviewed, only first contact with a medical provider was taken as a reference point when analyzing delays. However, one study from the Gambia (19) incorporated all health providers in this regard. In the current study, all health providers were considered as a reference point for analysis. This is because, in Ethiopia, all health providers are assumed to be potential sources of health care for TB patients. 4.3 The role of knowledge, perception and behavior in diagnostic delay In the health seeking behavior model, the process of care seeking begins with “symptoms recognition” (77). Likewise, in the present study, we observed an alternative explanation for the symptoms of TB among the respondents. In the initial period of the onset of cough, 61.4% of the respondents attributed their cough to other conditions like nefas (bird). Nefas/bird in Amharic simply means wind blown to the chest. It is also seen in relation to exposure to the cold (any cold element, like the cold water). It is a traditional phenomenon but not a scientifically explained disease. Similar finding was observed in a recent unpublished qualitative study that was conducted in Addis Ababa the capital of Ethiopia, which showed that the first symptom of TB (cough) was often not directly related to TB. The patients’ belief was that they had bird (57). Other studies conducted in Colombia, attributed TB symptoms to flue (52). In Malawi TB symptoms were attributed to tsempo, mphumu or modulo which is a traditional folk condition believed to be caused by careless sexual behavior or adultery (54). In Ethiopia, there is a strong belief that nefas /bird causes samba nekersa (pulmonary TB). Especially a narrowly opened window (while traveling in a car or sitting in a room) is believed to be dangerous as a sharp wind could come through it with a power enough to penetrate the chest and then directly to the lung causing TB. It is a common phenomenon to observe many people taking preventive action against nefas/bird. For example, when people are traveling by a taxi or a bus, windows are usually closed. My own experience confirms this. As I was frequently traveling for supervision purpose during the data collection period of this study, I some times used public transport like bus. In the bus, we were sixty traveling 470 Km together. From the time we departed till we reached at our destination, all the windows were closed. As I suffered from sever headache and suffocation, I tried to open the window once, every body shouted at me saying that, "You guy! nefas is coming! Shut the window! Please! Please!" then I immediately closed. The only time we got fresh air was when the bus stopped for breakfast and lunchtime. This clearly shows that, the wrong perception among the people is causing them to behave in the wrong way. All this may be related to lack of awareness regarding the causes of TB among the population. According to the health seeking behavior model, the first step in symptoms recognition includes also identifying the causes and the severity of symptoms (77), in the present study, we found that patients with haemoptysis had longer duration of illness compared to those with out haemoptysis. It seems that patients wait for long time until they recognize sever symptoms like (haemoptysis). The reason for this may be related to the subject’s perception of severity of diseases. Patients may assume that, when the cough gets severe, like accompanied with haemoptysis or dyspnea, it is an indicator that the nefas/bird has penetrated the lung, at this time they may be motivated to take one step forward in the health seeking behavior, i.e. they might immediately go to a medical facility. As severe weight loss and severe cough were strongly related with TB in other countries (52), haemoptysis might have been considered as the major sign of TB not cough alone by some of our respondents. Following the health seeking behavior model (77), the next step was consulting the symptoms with laypersons and making a decision about treatment. Likewise, our result showed that the majority (88%) of the subjects consulted family members regarding what to do in the next step. They also decided to use selftreatment (home made) like variety of hot fluids and steam inhalation. The practice of self-treatment in response to the initial symptoms is also evidenced in the recent un published Ethiopian study where patients were taking different homemade remedies to relieve their cough (57). Studies conducted in other African countries such as Ghana (16), Botswana (18) and Kenya (49) showed also the same result. Other studies from Pakistan (74) and Malawi (62) reported that beliefs about the etiology of TB were associated with the health seeking behavior. For example, people who believe that TB is caused by supernatural forces would seek care from folk and traditional healer (62). According to Kleinman, this seems a universal phenomenon in which case the response to early symptoms of disease as well as their action upon it is within “the popular sector” of the health care system (77). Kleinmans (1980) described health care as a local cultural system consisting of three overlapping parts; the popular, the professional and the folk sector. The popular sector is the largest part of the system, consisting of a matrix containing several levels; the individual level, the family level the social network and the communities’ beliefs and activities. It is within this sector that, illness is first defined and different health care activities initiated. It is also within this sector that a large percent of illness episodes are managed. Self treatment by the individual and his or her family is the first therapeutic intervention people make use of in a wide range of cultures, and when people turn to folk medicine, and/or modern western medicine, their choices are often based on the belief and the value orientation of the popular sector (77). Generally, from the above explanation, we can see that, initially patients had wrong perceptions regarding the causes of TB. As a result, they attributed their illness to other diseases and stayed at home taking self-treatment. Some of them even stayed till they noticed an alarming symptom like haemoptysis. This has resulted in a considerable delay before diagnosis and was clearly shown in findings section by the association between self-treatment and patients’ delay being significant. 4.3. The contribution of the different health providers in diagnostic delay 4.3.1 Drug retail outlets In this study, drug retail outlets were very much utilized among TB patients in the early period of their illness. The result showed that 31% of the study subjects used self-medication at the onset of their symptoms. Buying drugs from drug retail outlets might indicate a preference for the more convenient way of getting medicine. Previous studies from Northwest and southern Ethiopia reported a higher prevalence of self-medication with a proportion of 24 and 27.6%, respectively (79). Other studies in Mexico (75), India (80) and China (81) showed 30%, 34.5% and 32.5% prevalence of self-medication, respectively. However, the current study might not be directly comparable with these studies as one disease entity is investigated while the other studies considered all diseases symptoms. On the other hand, the major symptoms that led patients to selfmedications in those studies were headache, fever and cough which are also often symptoms experienced by TB patients For self-medication, the study subjects reported that they used antibiotics like ampicillin capsules and penicillin injections and said that they got improvement with their cough after taking these drugs. Other studies (62) have noted that respiratory symptoms in patients with microbiological confirmed TB can temporarily subside after a course of antibiotics. This may be due to some antibiotics having a short mycobacteriostatic action or because of bacterial super infection. Whatever the reason may be, symptomatic improvement after a course of antibiotics may contribute to a delay in diagnosis as has been found in other parts of sub Saharan African countries (62). Currently in Ethiopia, following the new health sector reform, quite a number of drug retail outlets have been opened (3). Therefore, it is relatively easier to buy drugs from drug retail outlets rather than going to a medical facility, which in fact may cost additional money including transportation cost. One can find different kinds of antibiotics in the drug retail outlets. Sometimes, even anti-TB drugs might also be found (12) indicating the common practice of selling drugs without prescription. Even though there is a law that forbids the selling of such drugs without prescription. It seems that the guideline of the regional health bureau is not being respected. As WHO noted, self-medication provides a cheep alternative for people who cannot afford to pay a medical practitioner. Thus selfmedication is often the first response to illness among people with low income (83) and all these might contribute to patients’ delay. 4.3.2 Traditional health care providers Traditional health care providers were among the sources of health care visited by the study subjects. The findings showed that 27% of the subjects initially visited traditional health care providers. This is nearly similar to the finding of the study done in Malawi (62) where 30 % of the study subjects initially visited traditional health care providers, but lower from Tanzania where the proportion of first visit to traditional health providers was 39% (50). In Ethiopia, modern health service utilization appears to be generally low. An earlier study which summarized the health profile of 52 districts reported that the per capita annual number of visits was 0.23 visits over all, with the mean for urban double that of the rural district (84). The vast majority of the Ethiopian population, therefore, still depends on traditional medicine and its practitioners. The 1982- 1983 rural health survey revealed that more than half of the health service seekers relied on traditional healers. In Addis Ababa, which is one of the highly urbanized centers of the country and where modern health services are relatively accessible, 26% of the representative populations were shown to have used traditional medicine (9). According to the 1999 World Bank report, more than 80 % of the people use herbal remedies as their first choice for the day today health care needs (85). Traditional medicine remains of paramount importance to the Ethiopian people and Commands a great deal of acceptance among the majority of the population. The widespread use of traditional medicine in the country among both rural and urban population could be attributed to the following major factors (9). 1. Acceptability: Use of medicinal plants constitutes part of the cultural heritage representing the identity and the uniqueness of our society. Traditional medicine is a component of the local culture. People resort to it even when there is demonstrably better alternative care. 2 Accessibility and affordability, as compared to modern drug. Medicinal plants are often within easy reach and affordable both in terms of financial resources and time when compared to modern drugs dispensed in remotely located health institutions Moreover, in Ethiopia, it is a common phenomenon that patients who have visited traditional health providers normally do not seek formal health care from medical providers till they finish the ordered herb/other remedy by the traditional health provider for a given period of time. There is also a cultural belief that, the herb/other remedy given by the traditional health provider would not work if one took injections or tablets from the modern medicine at the same time. This and the above mentioned reasons might delay patients for a considerable period of time before seeking health care from the formal health providers for diagnosis. 4.3.3 Private medical providers In the present study, 24% of the subjects had their diagnosis from the private medical providers and were significantly delayed compared to those directly diagnosed in the TBMU. Even though TB treatment is offered exclusively in the public sector, many studies have revealed that patients tend to be under private care for a considerable length of time before TB is diagnosed and patients are referred to the TB service. For example, in Sao Paulo city (86) where TB care largely takes place in the public sector, an analysis of the place of first diagnosis and the extent of delay in diagnosis showed that in about 20% cases the diagnosis was first made in the private sector. The mean delay in diagnosis was 12.5 weeks. In the Kenyan study (88), 90 % of TB suspects claimed that they had attended private health care facility yet 65% had neither a chest radiograph taken nor their sputum examined. A study of TB patients and practitioners in private clinics in India (89) showed median delay in diagnosis of about 2 to 3 weeks among urban and rural patients after they sought help at private clinics. About 33% of the urban patients and 36% of the rural patients had not been diagnosed even after 4 weeks of seeking help. Another study in Vietnam (89) showed that patients who had first turned up to a private physician were more likely to have a long provider delay compared to people who had first turned to the national TB control program. This might show that private providers follow poor diagnostic practices leading to long delays in diagnosis. In the present study, it was also revealed among some patients that, private medical providers instead of referring suspected/confirmed cases of pulmonary TB to the TBMU, they prescribed anti-TB drugs and informed the patient to directly purchase the drugs from private pharmacies. This practice is clearly against the guideline of the national TB control programs, which indicates that there might be poor control of the private medical providers by the district, zonal or regional health bureau. The availability of anti-TB drugs in the private pharmacies might lead to irrational use of drugs, which ultimately can result in the emergence of drug resistant TB in the region that will make the TB control program unsuccessful (12). 4.3.4 Local injectors The study showed that considerable number (3.6%) of the subjects visited local injectors during the onset of their illness. According to the ANRSHB (2002) there exists a practice both among the private practitioners as well as the local injectors to give injections like penicillin, vitamins and saline water for patients with nefas/bird. Similar observation was made in the previous unpublished Ethiopian study where saline water was extensively given as injections (57). The use of injection is also high in other sub-Saharan African, Middle East and South East Asian countries by the informal private providers (90). Local injectors in Ethiopia are part of the health care system both in the urban and rural areas. They may or may not have medical education but they administer injections to patients presenting to them. They are not legally allowed to practice as a local injector in any way. The procedure is usually performed behind closed doors. Ethiopian patients especially in rural areas strongly prefer injections to tablets. This may be related to the belief prevailing among the population that, “injections radically remove the disease compared to oral medications.” Patients might understand the pain that they feel during the injection procedure as a sign that the disease is gone forever. Many patients are dissatisfied if medications are not given while diagnostic tests are pending or the illness does not necessarily call for medication (91). Therefore, due to the strong belief in injection among the population, considerable numbers of people might go to local injectors for their illness. As a result a placebo effect may cause delay in diagnosis among TB patients. Strengths of the study 1. Relatively large sample size was taken 2. We were able to meet the intended sample size within the study period 3. Very close supervision was conducted and the data collection activity was successfully accomplished 4. We did additional analysis on other variables besides our original objectives Weaknesses of the study 1. We were not able to collect data on sputum grading. Because, most of the TBMUs were not doing it during the study period. Therefore, we were not be able to analyze the infectivity versus the duration of illness Limitations of the study There are limitations to our study. One of the limitations is related to the interviewers. We used health professionals to conduct the interviews. In this regard, we have a suspicion that subjects might underestimate the duration of stay at TBMUs for fear of being mismanaged by health professionals during subsequent visits. The second one is related to selection bias. We included patients presenting to government health care facilities. Other pulmonary TB patients who might probably go to private medical providers and who stayed at home during the study period were not included in our study. Here it might be difficult to consider our study result as representative of all smear positive TB patients at national or regional level. Because, the nature and behavior of patients that were not included in our study might vary. However, we have a strong belief that, our sample is representative of the smear positive pulmonary TB patients presenting to TBMUs in Amhara region as we managed to select the representative health facilities. We were also generally able to interview 35% of the total diagnosed cases in the region during the study period. The other problem is related with the recall of the duration of illness. We interviewed our subjects retrospectively to tell us what happened during the initial period of their illness. Therefore, when we see it from the angle of validating the duration of illness, it may suffer from recall bias in some of the respondents as they might not be able to tell us the exact date of onset of their illness. However, we have put in our maximum efforts to minimize this problem. We specifically asked the onset of the major symptoms and how long after these symptoms they consulted a health provider. As described earlier 96.4% had cough that is likely to be remembered by the subjects. Moreover to estimate the date of onset of symptoms, we have used local calendar listing the main religious and national days. As Christianity is the predominant religion in the study area, it is expected that the people might remember these days. As shown earlier in our results section, the length of recall period for the majority (69%) was below 2 months. Therefore, we might say that, the possibility of recall bias is very much reduced though it is admittedly difficult to eliminate it altogether. As a data collection tool, we used structured questionnaires. We had also some semi-structured questionnaires. We believe that the tools were appropriate in gathering the information for our research questions. These methods are the most commonly employed methods used to gather information for crosssectional studies where the numbers of respondents are usually large (92). However, there are some disadvantages of using these tools. Like for example, the interviewer may inadvertently influence the respondents, important information may be missed, because spontaneous remark by respondents is usually not recorded or explored, and open-ended questionnaires are difficult to analyze. To control these problems, all the interviewers were instructed to take all the necessary care during interviewing to make the respondents as free as possible with regard to responding as fully as they felt, the interviewers comprised also both males and females (30% of the interviewers were females). All were from the same ethnic group who were well aware of the socio-cultural issues in the study area, they were also local residents who spoke the native language, and in analyzing the open ended questions, after the data were collected, we went through all the possible responses and carefully categorized them for analysis. Chapter 5: Conclusions & Recommendations Generally, our study showed that there was a significant delay in the initiation of anti-TB chemotherapy among smear positive pulmonary TB cases in Amhara region. This delay was to a large extent attributed to the long health providers’ delay. Eighty one percent of the delay was due to the health providers, and the overwhelming majority (61.7 %) of pulmonary TB patients in the region attended non-formal health providers as their first preference when symptoms initially started. To our surprise we found that patients seek health care relatively early and the type of health provider they visit vary greatly. By saying this, we are not totally denying the contribution of the patients’ delay to the total delay, as 48% of the subjects took more than 30 days prior to reporting to the medical providers. The major factors associated with the patients’ delay were related to the wrong perception regarding the causes and symptoms of TB and related behaviors (self-treatment), lower access to medical providers and prior attendance to the non-formal health providers. On the other hand, the major factors associated with the health systems’ delay were prior attendance to the health posts and private medical providers. These were the potential risk factors affecting patients’ and health systems’ delay in the diagnosis of pulmonary TB in Amhara region. The median diagnosing facilities’ delay observed in this study is relatively short though it still needs to be reduced further. It indicates that the TBMUs are doing an encouraging job in the region. Over all, considering the high magnitude of delay in the region, the abovementioned factors should be an area of focus for the regional health bureau to start acting on them so as to lower down the current unacceptable long duration of pretreatment period and reduce transmission of TB in the community. Therefore, the following recommendations are made based on our findings. Recommendations 1. There should be an access for a simple and rapid diagnostic test for TB at the lowest health care facilities (health posts/clinic) so as to reduce the health systems’ delay. 2. A mechanism has to be created to work closely with all non-formal health providers including drug retail outlets, traditional healers, herbalists and religious healers in the region on how to identify TB suspects and instant referral. This could be done through workshops, seminars, conferences and trainings organized by the RTLCP. 3. It is important that health workers working at the peripheral health care facilities be more alert to the possibility of pulmonary TB in patients with respiratory symptoms. So that it can be diagnosed early and treated promptly to reduce patient morbidity as well as to limit its spread in the community. Efforts should be made to improve the diagnostic skill and the awareness of TB among all health workers particularly, nurses and health assistants since most patients first seek treatment from them. Education on the clinical identification of suspects, public health aspects of TB and the importance of referral should be intensified at undergraduate level in the nursing schools. There should also be continuing medical education about TB in the form of lectures, conferences or seminars to other health workers such as health officers and medical doctors working at the diagnosing facility level to maintain a high index of suspicion for TB and perform appropriate diagnostic tests. These all might be organized by the RTLCP, NGOS and professional organizations working in the region 4. Well-organized and integrated information, education and communication (IEC) program has to be put in place to raise the awareness of the population in general on the symptoms and treatment of TB and facilitate prompt utilization of the available health service. Using the available media such as the regions radio and newspaper for the dissemination of health information to the general population should be given due emphasis. 5. Increased knowledge of patients’ health seeking behavior and their selfperception of disease is useful for health workers and should have implications for health education messages 6. In this study, far distance between home and health care facility has affected the early initiation of treatment. Therefore, efforts should include improving easy access of diagnostic facilities to the population by further decentralizing the TB diagnostic and treatment services to the periphery are necessary. Besides this, there should be a mechanism to collect sputum samples from the remote areas. In this regard, incorporating the community health workers might be important. 7. The regional TB control program has to device a system for the private sector to effectively participate in TB control activities. This could help in reducing health systems’ delay. Moreover, it is important to give training to the private medical providers about the clinical and public health aspects of TB. 8. Regular and intensive supervision including the government and the private medical providers should be strengthened to assure the quality of care given to TB patients. The supervision should also include all drug retail outlets aiming at controlling the availability of anti-TB drugs in the private pharmacies. 9. In this study, we observed that due to the wrong perception of the causes and symptoms of TB, patients were treating themselves for a considerable period of time prior to presenting to medical providers. Besides this, the health service coverage in the region is low. Therefore, with only using passive case finding, it might be difficult to reach as many pulmonary TB patients as possible. Therefore, we believe that it is important to incorporate active case finding, like contact tracing in the current TB control system in the region. 4.12 Further research implications 1 Further study should be conducted to see the relation between longer pre-treatment delays and its effect on treatment outcome on the already studied patients. 2 The magnitude of individuals having suspected symptoms of TB but did not seek treatment should be explored to better understand the impact of diagnostic delay in the case finding activity in the region. 3 As described in our introduction section, the report of the regional state health bureau has revealed that the case holding activity in the region has currently encountered challenges in its implementation. Some of the challenges include poor recording and reporting, poor patient follow-up, high staff turn-over and in general poor management of DOTS. Therefore, looking into the quality of TB control in the region might help to understand the underlying problems and improve the TB control program in the region. 4 The role of private medical providers in TB diagnosis in the region needs to be assessed. This will help to generate information that can be used for designing better cooperation between the government and the private sector in TB control in the region. 5. In this study we have observed that some of the respondents were able to access anti-TB drugs from various drug retail outlets. We know that this is against the guideline of the NTCPs as it can lead to irrational use of anti-TB drugs. Therefore, we think it is wise to conduct a baseline survey for assessing anti-TB drug resistance in the region. 6. Information regarding TB and HIV co-infection is lacking in the region. In the present study we found 47% of the TB patients associating TB with HIV. 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Ethiop J health Dev. 1994; 8: 87-89 85. World Bank. Conservation and sustainable use of medicinal plants in Ethiopia. World Bank report No 19134 ET, New York 86. World Health Organization. Involving private practitioner in TB control, WHO/CDS/TB/2001. 285 Geneva, Switzerland 2001. 87. Aluoch JA, Edwards EA, Stott H, Fox W, Sutherland I. A fourth study of casefinding methods for pulmonary tuberculosis in Kenya. Trans R Soc Trop Med Hyg. 1982; 76(5): 679-91. 88. Uplekar MW, Rangan S, Weiss MG, Ogden J, Borgdorff MW, Hudelson P. Attention to gender issues in tuberculosis control. Int J Tuberc Lung Dis. 2001 Mar; 5(3): 220-4. 89. Lonroth K, Thung L M, Linh P F, Diwan V K. Utilization of private and public health care providers among people with symptoms of tuberculosis in Hochiminh city, Vietnam. Health Policy and planning. (In Press) 90. Hutin YJ, Hauri AM, Armstrong GL. Use of injections in healthcare settings worldwide, 2000: literature review and regional estimates. BMJ. 2003 Nov 8; 327(7423): 1075. Review. 91. Hodes R. Cross-cultural medicine and diverse health beliefs. Ethiopians abroad. West J Med. 1997 Jan; 166(1): 29-36. 92. Corlien M. Varkevisser Indra pathmanathan, Ann Brownlee. Designing and conducting Health systems research Projects. 2nd ed. Vol. 1&2. Ottawa. Canada: IDRC; 1995. p. 160-162. Appendix 1 Questionnaire for patients This is a questionnaire prepared for assessing patients’ and health systems’ delay in the diagnosis of pulmonary TB in Amhara region Northwest Ethiopia. It will be used as a tool for our research which is part of the partial fulfillment of the master of philosophy degree in international community health at the University of Oslo, Norway. We will be asking you about socio-demographic and health services issues which are related with your present illness. In this regard, your honest answers are very valuable and will help to improve the TB control program in Amhara region. It is not bad or embarrassing if your answer is I do not know or I do not remember, since we need to find out what the people know not yet know in order to improve the TB control program in the region. Solomon Abebe, M Phil 2nd year student Department of General Practice and Community Medicine, Section for International Health University of OSLO, Norway Participant number___________________Date of interview________________________ Date of interview_____________________ Name of the health facility___________________ Name of the interviewer_____________________ A. Personal and socio demographic information: 1(GENERAL) 1.1 Age in years:_____________________ 1.1.1 Address: __________________ 1.2 Sex: 1. 1.3 Literacy: Male □ □ 2. Female 1.Unable to read and write □ 3. Secondary (9-12) □ 2.Primary (1-8) □ 4. College □ 5. Other, please describe______________________ 1.4 Occupation: _____________________________________ 1.5 Marital status: Widowed 1. Never married □ 2.Divorced □ 3.Married□ 4. □ 1.6 Religion: 1. Christian □ . 2 Muslim □ 3.Other________________ 1.7 Do you have children? 1. Yes □ 2. No □ If yes, how many? _____________________________________ 1.8 Can you take decisions on your own where to go for help during your illness (for women)? 1. Yes □ 2. No □ 1.8.1 If no, whom do you consult in the family? ______________________________ 1. 9 Distance from home to the health center/hospital______________ Km/Hrs of walking distance 1.10 Type of house used for dwelling 1. Hut □ 2. Corrugated sheet iron roof □ 3. Other, please describe_______________ 1. 11 Number of rooms in the house____________________________________________ 1.12 Number of people living in the house_______________________________________ 1.13 Income 1.Regular □ 2. Irregular □ If regular, how much per month? ___________________________Birr For those who are self-employed ask the average earning per month and take this average as an average monthly income. B. Current habits: 2. Do you smoke cigarettes? 1. Yes □ 2. No □ If yes, how long have you smoked? __________________________Years, months 3. Do you drink alcohols? 1. Yes □ 2. No □ 3.1 If yes, how long have you drunk__________________________________ 4. Do you chew khat? 1. Yes □ 2. No 4.1If yes how long have you chewed__________________________Years, months C. Current illness/ health provider visit: 5. Date of onset of the present illness: _____________________________ 6. Which of the following symptoms did you suffer? Symptoms Yes No Duration of □ symptoms in (days/ Weeks/months/years Cough haemoptysis Fever loss of appetite chest pain Tiredness weight loss Night sweating Other symptoms, please specify_____________________________________________ 6.1 Which of the above symptoms most urged you to seek for medical care? ________________________________________________________________________ 6.2 What did you think of the type of disease you have? _______________________________ 6.3 If the answer to question number 6.2 is nefas /or bird, do you think nefas causes TB? 1. Yes □ 2.No □ 6.3.1 If yes, how does it cause TB? Please describe ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________ 6.4 Did you consult a person about what to do/where to go for help at the onset of the present illness? 1. Yes □ 2. No □ 6.4.1 If yes, whom did you consult? Please describe_________________________________________________________________ To the interviewer: If the patient can not remember the name of the drug, please ask the color and shape of the drug._______________________________________________________ 6. 5. Did you first try to treat the illness (cough) by your own using home made remedies? 1. Yes □ 2. No □ 6.6 If yes, how did you try to ease the symptom (cough)? Please, describe ________________________________________________________________________ ________________________________________________________________________ 6.6.1 How long did you take these remedies? ___________________________days or weeks 6.6 Did you first buy any drug from any drug retail outlet to cure your illness by your own 1.Yes □ 2.No □ 6.6.1 If yes, what kind of drug did you take? Please describe___________________________________________________________ 6.6.2 Did you get improvement after taking this drug? 1.Yes □ 2.No □ 7. Which of the following health providers did you first visit? Public health care facilities Yes Date of first Duration of visit cough from date of onset to first visit in Number (days, weeks, month/year) 7.1 Clinic /health post 7.2 Health center (Government) 7.3 Hospital (Government) 7.4 Lower level clinic (private) 7.5 Mid level clinic (Private) 7.6 High level clinic (private) 7.7 Local injectors 7.8 Pharmacies, drug stores, open market drug sellers, others 7.9 Traditional health providers (herbalists, religious healers, holy water, wodaja, others. For 7.8 and 7.9 please underline the specific health provider. 8. If the patient took more than 3 weeks before he/she visits a medical provider, what was the most important reason (as perceived by the patient) for taking such a time? 1. Illness considered harmless □ 5. Lack of money □ 2. The health care facility is far □ 6.Cold weather □ 3. Self-treatment considered sufficient □ 7. Fear of being tested for HIV □ 4. Fear of being diagnosed as TB □ 8. Lower belief in modern medicine □ Other, please describe_______________________________________________________ 9. How many times have you visited a government medical provider for your symptoms before it was confirmed to be TB? □ 2.Twice □ 3.Three times □ 4. Four times □ 5. Five times □ 6. More than five□. 1. Once 9.1Were the above visits with the same or different medical providers? □ 1. Same 2.Different □ 9.2 Did the doctor ordered investigations for you at that time of illness? 1. Yes □2.No □ 9.3 If yes, which of the following investigations were done? Sputum examination Chest x- ray □ 1.Yes □ □ 2. NO □ 3. I do not remember□ 1. Yes 2.NO 10. How many times have you visited a private medical provider for your symptoms before it was confirmed to be TB? □ 2.Twice □ 3. Three times □ 4. Four times □ 5.five times □ 6. More than five□. 1. Once 10.1Were the above visits with the same or different private medical providers? 1. Same □ 2. Different □ 10.2 Did the physician at the private medical provider ordered investigations for you at that time of illness? 1.Yes □ 2. NO □ 10.3 If yes, which of the following investigations were done? □ 1.Yes □ Sputum examination 1.Yes Chest x-ray □ 2. NO □ 2. NO □ I do not remember 11. Where did it become for the first time clear that the disease is TB? 1. TBMU 2. Private medical provider □ □ D. If the diagnosis of TB was made at the private medical providers 12. What did the doctor/ the health worker at the private medical provider do when he/she confirmed that your illness was TB? □ □ □ 1. He/she referred me to the TBMU with slides 2. I was referred with out slides 3. I was given a prescription and sent to a pharmacy to buy anti TB drugs Other, please describe________________________________________________ 12.1 If given prescription, Did you get the drugs in the private pharmacy? 1. Yes 12.2 If yes, did you purchase? □ 2. No □ □ 2.No □ 1. Yes If no, why not? 1. It was expensive 2. I thought it was fake □ □ 3. Other Please describe ______________________ 13. How long did it take from the time you were referred by the private medical provider till you first reported to the TBMU?_______days/weeks. 12.4 When you reached at the government (TBMU) with your referral, what did they do? 1. Re examined me 2. Requested AFB 3. They accepted my slides and started me on treatment 4. Other, please describe________________________________ □ □ □ 14. How long did it take from the time you first reported to the TBMU till you first started anti-TB drugs? ____________days/weeks 15. How long did it take from the time you were referred by a medical provider till you first started taking the anti TB drugs?_________________________days/weeks. E. Diagnosis made at theTBMU 16. Date of first visit to the TBMU? __________________________________________ 17. How did you decide to visit the TBMU? __________________________________ 1. Referred by HP/clinic □ Date Referred________________ 2. Self-Referred □ Date referred_________________ 3. Referred by private □ Date referred_________________ 4. Others, please specify, ___________________________________________________ 18. How long did it take since you came to the TBMU till you were first seen by the doctor/ health worker? _________________________ days/weeks 19. Date the patient was first seen by the doctor /health worker checked__________________ 20. How long did it take from the time you were first seen by the doctor/ health worker till you first received the sputum request for AFB? ___________days/ weeks 21.1 Date first sputum for AFB /x-ray was requested checked_______________________ 21.2. Date the patient gave the sputum for AFB___________________________________ 21.3. Date sputum Result was registered in the laboratory registration book checked______________________________________________________________ 22. Grading of sputum (Lab. register) scanty 1.+1 □ 2. +2 □ 3. +3 □ 23. How long did it take from the time you gave sputum for examination till you received the results?_________________________________________________________________ 23.1. Date the patient first received results checked_____________________________ 24. How long did it take from the time you were notified to have TB (received AFB result) till you started the first Anti- TB regimen? ______________________ days/weeks 24.1 Date Anti-TB treatments were ordered checked (from the patient card) ____________________________________________________________________ 24.2 Date of registration for treatment (from district registry book) Checked_____________________________________________________________ 25. How long did it take from onset of the present illness till you first started anti TB chemotherapy? ____________________________ (days, weeks, month) 26. How much money did you pay for all the consultations & medications from onset of cough till the diagnosis of TB? _____________Birr. E Knowledge of TB: 27. Have you heard, known something about pulmonary TB? For example, TB causes chronic cough? Haemoptysis? 1. Yes □ 2. No □ 27.1. If yes, where has the information come from? □ 2. Neighbors □ 5. Media □ 1. Family 3. Friend □ 4.Health workers 5. Books (reading) □ □ Other, describe_________________________________________________ 28. If TB is treated, can it be cured? 1. Yes 29. What do you think are causes of TB? Possible causes No Witchcraft Poverty Bacilli hard work Sexual overindulgence Malnutrition Unventilated home Living together with untreated TB patient HIV other causes □ 2. No□ 3.I do not know yes 31. Do you know any danger if a TB patient is not treated? 1.Yes □ I do not know □ 2. No 31.1 If yes, what is it? For the patient, ____________________________________________ For the people around, ________________________________________ □ 32. Do you know that the drugs are available free? 1. Yes □ □ 3. I don't know 2.No □ 33. How long is TB treated? 1. 1-year □ 6-8 months 2. □ I do not know □ 3. Other, please describe__________________ F. Stigma: 34. Do you feel TB is a social stigma? □ 1. Yes □ 2. No 35. Before you came to this health facility, was there any fear in your mind that you would be tested for HIV? 1. Yes □ 2. No □ 36. Do you think people will avoid your company because you are a TB patient? 1. Yes □ □ 2. No 37. In your opinion going to the health center for TB test can make other people think that you have HIV/AIDS? 1. Yes □ 2.No □ 1. Yes □ 2.No 3. I do not know □ 38. Does TB has an association with HIV? □ 3. I do not know □ 39. Do you fear not to enter others social circle in fear that they will not accept you? Yes Thank you!! □ □ No