Abstract
Background
Data on the epidemiology of tuberculosis and its treatment outcomes were incomplete in the study area and this study was done to fill this gap.
Methods
Institution based cross sectional study was conducted from January 2011 to December 2014. A total of 949 TB patients who were on treatment in North Eastern Ethiopia, Eastern Amhara region were included. Data was analyzed using SPSS version 20. Frequency, percentages and means were used to present data. To assess the associations of treatment outcomes with sex, age, type of TB and human immunodeficiency virus (HIV), logistic regression was used.
Results
The proportion of smear positive and negative pulmonary TB, and extra pulmonary TB were 187/949 (19.7%), 322/949 (33.9%) and 440/949 (46.4%), respectively. Treatment success rate was 853/949 (89.9%). Smear positive pulmonary TB and TB/HIV co-infections were significantly associated with unsuccessful treatment outcome, P≤ 0.002.
Conclusion
Extra pulmonary TB was the most prevalent types of TB followed by smear negative pulmonary TB. Treatment success rate was above the WHO target of 85%. The causes for the high proportion of smear negative PTB and EPTB should be further investigated. Special emphasis should be put on smear positive PTB patients and TB/HIV co-infected patients to decrease unsuccessful treatment outcome and TB transmissions.
Keywords: Tuberculosis, types of tuberculosis, treatment outcomes, Ethiopia
Background
Tuberculosis (TB) is a disease of centuries. It killed more persons than any other infectious diseases1. Tuberculosis is a disease of poverty and mainly affects poor countries. A person with TB loses, on average, 20–30% of annual household income due to illness2.
Acid fast bacilli (AFB) microscopy with spot-morning-spot sputum sample collection strategy was the recommended technique for the diagnosis and follow-up of pulmonary TB (PTB) patients in the Directly Observed Treatment short course (DOTS) program3–5. Effective treatment of TB started in 1946, with the introduction of streptomycin (SM). The main problem with current chemotherapy is too long duration of treatment regimen thus allowing opportunities for interruptions in drug taking that may lead to the emergence of drug resistance6.
Globally, the rate of treatment success among new smear-positive PTB who were treated in the 2012 cohort was 86%. Treatment success rate was higher among smear positive PTB than smear negative PTB7. In Ethiopia in the same year, TB treatment success rate among new TB cases was 91%5. However; it is unknown among retreated cases5.
There was no data about TB treatment outcome in the study area in particular. In addition, aggregate national data might not reflect the real TB profile and treatment outcomes due to subtle socioeconomic, geographic and methodological variations. Thus, studies like this might show the appropriate proportion of mean treatment outcome and types of TB in the specific area. Thus, this study was done to determine the profile and treatment outcome of TB patients in Amhara National Regional State (ANRS); Kobo and Raya Kobo Woredas of Ethiopia.
Materials and methods
Study setting, period and population
Institution based cross-sectional study was conducted on patients diagnosed and treated over the period of January 2011 to December 2014 in Kobo, Robit and Gobiye health centers. These health centers found in eastern Amhara region in north wollo zone, 552km away from Addis Ababa. The woredas are part of a mid-altitude area which lies between the Ethiopian Highlands to the west and the Afar depression to the east. Currently, there are 8 additional health centers in the studied area that provide TB diagnosis and treatment. However, these health centers were newly opened and had incomplete registration system to be included in the study.
Tuberculosis diagnosis and treatment strategy
The pulmonary TB diagnosis and treatment was based on the stop TB strategy. That is, sputum samples were collected using spot-morning-spot strategy and three slides were prepared, one from each sample. Slides were processed and examined using the standard Ziehl-Neelsen (ZN) AFB staining technique8.
Extra pulmonary TB was diagnosed at nearby government and private health institutions primarily based on clinical data with limited service of imaging and pathological examinations. Diagnosis of TB in children was based on clinical and X-ray findings.
For those patients diagnosed with active TB, the standard TB treatment regimen; 2(RHZE)/4 (RH) and 2S (HRZE)/1(HRZE)/5(HR) E were administered for new and previously treated TB patients respectively9.
Operational definitions
Health Center: A primary health care unit that serves a population of 15,000–25,000 and is comprised of specialized clinics like TB, antiretroviral treatment (ART), maternal and child health clinics.
Inclusion and exclusion criteria
All TB patients with complete demographic and clinical data were included in the study. Whereas, patients with unknown types of TB and treatment outcomes, including transferred out were excluded.
Data collection and tools
Demographic and clinical data such as age, sex, type of TB, TB treatment outcome, status of human immunodeficiency virus (HIV) infection, co-trimoxazole prophylaxis (CPT) and antiretroviral treatment (ART) status were retrieved from TB registry using data extraction sheets.
Data analysis
Collected data was entered, cleared, and analyzed using SPSS statistical software package (IBM Corp. Released 2011. IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp.). Frequency, percentage, mean and standard deviation (SD) were used to present data. To assess the associations of treatment outcome with sex, age, type of TB and HIV status; stepwise logistic regression model was used. Variables with a p-value of ≤0.2 PubMed in bi variate analysis were included in the multivariate analysis.Associations were determined using odds ratio and 95% confidence interval. A p-value of < 0.05 was considered to indicate statistical significance.
Ethics statements
This study was approved by Amhara Regional Health Bureau Institutional Ethical Review Board (IRB) to utilize the data. No patient details that may link to the patient identity were used and the confidentially was maintained.
Results
Demographic epidemiology of tuberculosis
Among the total of 990 TB patients registered on TB notification books, 30 (3%) were transferred out and 11 (1.1%) were with unknown treatment outcomes. We excluded these categories of patients. Thus, data from a total of 949 TB patients were included for analysis. Of the total included, 528/949 (55.4%) were males. Mean age of participants were 32.8 years with SD of 16.3. Moreover, high proportions of TB patients; 285/949 (30%) and 212/949 (22.3%) were in the age groups of 25–34 and 15–24 years, respectively [Table 1].
Table 1.
Distribution of demographic characteristics and HIV status among tuberculosis patients in Kobo and Raya Kobo Woredas-Ethiopia, 2015.
| Type of Tuberculosis | |||||
| Variables | PTB+ | PTB− | EPTB | Total | |
| N (%) | N (%) | N (%) | N (%) | ||
| Sex | Female | 91 (48.6) | 133 (41.3) | 197 (44.7) | 421 (44.5) |
| Male | 96 (51.4) | 189 (58.7) | 243 (55.3) | 528 (55.5) | |
| Age | <=14 | 5 (2.7) | 29 (9) | 61 (13.9) | 95 (10) |
| 15–24 | 51 (27.3) | 66 (20.5) | 95 (21.6) | 212 (22.3) | |
| 25–34 | 70 (37.4) | 94 (29.2) | 121 (27.5) | 285 (30) | |
| 35–44 | 25 (13.4) | 43 (13.3) | 53 (12) | 121 (12.7) | |
| 45–54 | 18 (9.6) | 44 (13.6) | 47 (10.7) | 109 (11.5) | |
| 55–64 | 11 (5.9) | 21 (6.5) | 38 (8.6) | 70 (7.4) | |
| >=65 | 7 (3.7) | 25 (7.7) | 25 (5.7) | 57 (6) | |
| HIV Status | Unknown | 6 (3.2) | 6 (1.8) | 6 (1.4) | 18 (1.9) |
| Positive | 65 (34.8) | 87 (27) | 75 (17) | 227 (24) | |
| Negative | 116 (62) | 229 (71.1) | 35 9(81.6) | 704 (74.2) | |
| Total | 187 (19.7) | 322 (33.9) | 440 (46.4) | 949 (100) | |
Profile of tuberculosis
The proportion of smear positive PTB, smear negative PTB and EPTB were 187/949 (19.7%), 322/949 (33.9%) and 440/949 (46.4%), respectively [Table 1]. There was no significant difference on the types of TB with regard to sex and age of participants. The proportion of TB/HIV co-infection was 227/949 (24%). Moreover, TB/HIV co-infection was twice higher among smear positive PTB than EPTB [Table 1].
Tuberculosis treatment outcomes
The overall unsuccessful treatment outcome was 96/949 (10.1%) wherein failed, died and lost to follow up shared at 21/949 (2.2%), 47/949 (5%) and 28/949 (2.9%) respectively. It is found that the proportion of unsuccessful TB treatment outcome was higher among male and older age patients than their counterparts with no statistical significance. On the other hand, the proportion of cured was at 132/949 (13.9%) and treatment completed at 721/949 (76%) [Table 2].
Table 2.
Distribution of tuberculosis treatment outcomes by demographic and profile of TB patients, Kobo and Raya Kobo Woredas-Ethiopia, 2015. patients, Kobo and Raya Kobo Woredas-Ethiopia, 2015.
| Variables | Tuberculosis Treatment out come | Total N |
|||||||
| Successful | Unsuccessful | ||||||||
| Cured N (%) |
Completed N (%) |
Sub total N (%) |
Failed N (%) |
Died N (%) |
LTF N (%) |
Sub total N (%) |
|||
| Sex | Female | 63 (47.7) |
316 (43.8) | 379 (44.4) |
12 (57.1) |
19 (40.2) |
11(39.3) | 42 (43.7) |
421 |
| Male | 69 (52.3) |
405 (56.2) | 474 (55.6) |
9 (42.9) |
28 (59.6) |
17 (60.7) |
54 (56.3) |
528 | |
| Age | 0–14 | 5(3.7) | 86 (11.9) | 91 (10.7) |
2 (9.5) |
0 (0.0) |
2 (7.1) | 4 (4.2) |
95 |
| 15–24 | 36 (27.3) |
155 (21.5) | 191 (22.4) |
7 (33.3) |
9 (19.1) |
5 (17.9) | 21 (21.9) |
212 | |
| 25–34 | 54 (40.9) |
206 (28.6) | 260 (30.5) |
7 (33.3) |
9 (19.1) |
9 (32.1) | 25 (26.0) |
285 | |
| 35–44 | 16 (12.2) |
91 (12.6) | 107 (12.5) |
1 (4.8) |
9 (19.1) |
4 (14.3) | 14 (14.6) |
121 | |
| 45–54 | 10 (7.6) | 86 (11.9) | 96 (11.3) |
2 (9.5) |
8 (17.0) |
3 (10.7) | 13 (13.5) |
109 | |
| 55–64 | 6 (4.5) | 52 (7.2) | 58 (6.8) |
1 (4.8) |
7 (14.9) |
4 (14.3) | 12 (12.5) |
70 | |
| ≥65 | 5 (3.7) | 45 (6.2) | 50 (5.9) |
1 (4.8) |
5 (10.6) |
1 (3.6) | 7 (7.3) |
57 | |
|
Type of TB |
PTB+ | 127 (96.2) |
25 (3.5) | 152 (17.8) |
14 (66.7) |
14 (29.8) |
7 (25) | 35 (36.5) |
187 |
| PTB− | 0 (0.0) | 296 (41.1) | 296 (34.7) |
3 (14.3) |
14 (29.8) |
9 (32.1) | 26 (27.1) |
322 | |
| Extra PTB |
5 (3.8) | 400 (55.5) | 405 (47.5) |
4 (19.0) |
19 (40.2) |
12 (42.9) |
35 (36.5) |
440 | |
| HIV status |
Unknown | 5 (3.8) | 10 (1.4) | 15 (1.8) |
0 (0.0) |
0 (0.0) |
3 (10.7) | 3 (3.1) |
18 |
| Positive | 40 (30.3) |
148 (20.5) | 188 (22.0) |
7 (33.3) |
24 (51.1) |
8 (28.6) | 39 (40.6) |
227 | |
| Negative | 87 (65.9) |
563 (78.1) | 650 (76.2) |
14 (66.7) |
23 (48.9) |
17 (60.7) |
54 (56.3) |
704 | |
| Total |
132 (100) |
721(100) |
853 (100) |
21 (100) |
47 (100) |
28 (100) |
96 (100) |
949 (100) |
|
Furthermore, significant differences were observed on treatment outcome between smear positive PTB and EPTB, and between HIV positive and HIV negative TB patients [Table 3].
Table 3.
Association of unsuccessful treatment outcomes with possible predictors among tuberculosis patients, Kobo and Raya Kobo Woreda-Ethiopia, 2015.
| Variables | TB treatment outcome | Over all P-value of binary regression |
AOR (95% CI), P-value |
||
| Unsuccessful N (%) |
Success full N (%) |
Total (N) |
|||
| Sex: | 0.89 | ||||
| Male | 54 (56.3) | 474 (55.6) | 528 | - | |
| Female | 42 (43.7) | 379 (44.4) | 421 | ||
| Age: | 0.17 | ||||
| 0–14 | 4 (4.2) | 91(10.7) | 95 | 0.3(0.08–1), 0.06 | |
| 15–24 | 21 (21.8) | 191 (22.4) | 212 | 0.64(0.2–1.6), 0.35 | |
| 25–34 | 25 (26.0) | 260 (30.5) | 285 | 0.4(0.16–1.07), 0.07 | |
| 35–44 | 14 (14.6) | 107 (12.5) | 121 | 0.65(0.24–1.7), 0.4 | |
| 45–54 | 13 (13.5) | 96 (11.3) | 109 | 0.79(0.3–2.1), 0.66 | |
| 55–64 | 12 (12.5) | 58 (6.8) | 70 | 1.3(0.5–3.8), 0.5 | |
| ≥65 | 7 (7.3) | 50 (5.9) | 57 | 1 | |
| Types of TB: | 0.0001 | ||||
| PTB+ | 35 (36.5) | 152 (17.8) | 187 | 2.3(1.3–3.8), 0.02 | |
| PTB− | 26 (27.1) | 296 (34.7) | 322 | 0.88(0.5–1.5), 0.6 | |
| EPTB | 35 (36.4) | 405 (47.5) | 440 | 1 | |
| HIV Status: | 0.0001 | ||||
| Unknown | 3 (3.1) | 15 (1.8) | 18 | 2.6(0.7–9.6), 0.15 | |
| Positive | 39 (40.6) | 188 (22.0) | 227 | 2.6(1.6–4.27), 0.001 | |
| Negative | 54 (56.3) | 650 (76.2) | 704 | 1 | |
| Total | 96(10.1) | 853 (89.9) | 949 | ||
Discussion
This study revealed high proportion of TB among males than females. This agreed with different findings reported in Ethiopia and aboard5,10–13. The possible reason might be related with, lower rates of notification of TB among women than men due to low health seeking behavior, lack of financial control and stigma associated with being TB positive2. Majority, at 22.3% and 30% of TB patients were in the age groups of 15–24 and 25–34 years respectively. This report is also in line with other literatures5,10,14–15 which indicated that, TB mainly affects the reproductive segment of the population. This might be due to high HIV prevalence in these age groups (personal opinion).
The TB profile data showed that high proportions of TB patients were EPTB and smear negative PTB which is comparable with other Ethiopian TB profile data16. However, it is in contrary with reports from outside Ethiopia5,14,17–18. Currently, two justifications seems plausible: the role of false positive20/over prescription/ and the zoonotic transmission, social and host-pathogen genomic factors21. These two justifications are presented as follows;
The first argument discussed that, most of EPTB and smear negative PTB cases were diagnosed and transferred in from private health facilities. However, these facilities might not have well organized facilities and expertise to diagnose EPTB and smear negative PTB cases. This is in line with studies by Iwnetu et al. and Ehlers et al. According to these studies, up to 15% of all EPTB and 97.3% smear negative PTB cases were diagnosed wrongly19–20. Furthermore, clinicians might abused the low sensitivity of ZN and low specificity of pathological tests and might rushed to diagnose presumptive TB cases as confirmed smear negative PTB/EPTB (expert opinion)
The other justification goes in line with Berg et al, study justified that regular and direct contact with live animals, was a significant risk factor for EPTB21. These factors also seem likely, because, people in the study area are known live stock keepers and due to their local tradition, most of their domestic animals shared human shelter. Moreover, these people regularly use raw meat and milk. Moreover, the high smear negative PTB might be due to difference in the immunological and nutritional status of Ethiopian with other counties (unpublished report). However, to identify the real cause of such high prevalence report in Ethiopia, it needs further comparative ecological and cohort study.
In the present study, the proportion of TB/HIV co-infection was at 227/949 (24%), much higher than WHO report of the year 201522. Moreover, TB/HIV co-infection was twice higher among smears positive PTB than EPTB which is in contrary with a literature23. This can be explained by tailoring to Ethiopian situation. If the reports of Iwunetu et al. and Ehlers et al., mentioned above, considered as a possible cause for high rate of EPTB and smear negative PTB in Ethiopia, this would also dilute the TB/HIV co-infection rate among EPTB and smear negative PTB patients.
The odd of having unsuccessful treatment outcome was 2.3 times higher among smear positive PTB than EPTB patients (AOR: 2.3; 95% CI: 1.3–3.8; P: 0.02). This might be due to higher HIV prevalence, (34.8%) among smear positive PTB than smear negative PTB (27%) and EPTB (17%) [Table 1]. Similar finding was reported from Addis Ababa24.
The odds of having unsuccessful TB treatment outcome was 2.6 times higher among TB/HIV co-infected than HIV negative TB patients (AOR: 2.6; 95% CI: 1.6–4.27; p< 0.0001) (Table 3). This might be due to low level of immunity and drug mal-absorption25. This finding was in line with a study from Addis Ababa, Eastern Ethiopia, Benin and Malawi15,24,26,–27. Furthermore, the proportion of unsuccessful treatment outcome was higher among TB/HIV co-infected people with no history of CPT and ART than those on CPT and ART [data not shown]. Administration of ART is recommended during TB therapy regardless of the CD4 cell count,28 because ART is associated with reduction in mortality and HIV disease progression29–32. Moreover, all HIV-infected patients with active TB should receive CPT30,22
Limitation of the study
The recorded data lack detail clinical profile like CD4 count and other comorbidies. On top of this, due to the inherent limitation of the study design, the study couldn't show any cause effect relation between significantly associated variables.
Conclusions and recommendations
The proportion of smear negative PTB and EPTB were higher than smear positive PTB cases. Plus, the overall TB treatment success rate was above the WHO target of >85%. Moreover, smear positive PTB and TB/HIV co-infections were significantly associated with unsuccessful TB treatment outcomes. Thus, we would like to forward the following recommendations; (1) the causes for the high proportion of smear negative PTB and EPTB cases should be further investigated. (2) The ART and CPT coverage must reach 100% to TB/HIV co-infected patients so that their unsuccessful treatment outcome rate would be improved. (3) Especially emphasis should be paid to smear positive PTB patients to decrease unsuccessful treatment outcome and decrease transmissions.
Acknowledgements
Authors express deep appreciation to Amhara National Regional Health Bureau Research and technology department for approving the proposal. Moreover, we also thank North Wollo Zonal Health Department, Kobo and Raya Kobo Woreda Health Offices.
Funding
This research received no specific grant from any funding agency
Competing interests
We the authors declare that we have no competing interests.
Authors' contributions
DM substantially contributed in the design, statistical analysis, interpretation of data and drafting the manuscript. AD was involved in the data collection and entry, statistical analysis and enriched the manuscript. HM was involved in data collection, entry, and analysis. YZ critically revised the table and whole manuscript for intellec tual contents. All the authors read and approved the final manuscript.
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