The World Health Organization (WHO) declared TB a global public health emergency in 1993. Starting in the mid-1990s, efforts to improve TB care and control intensified at national and international levels. WHO developed the Directly Observed Treatment, Short-Course (DOTS), strategy within a decade, almost all countries had adopted the strategy, and there was considerable progress towards global targets established for 2005 [
Among the six WHO regions, the highest treatment success rates were in the Western Pacific Region, the Southeast Asia Region, and the Eastern Mediterranean Region. The treatment success rate was 79% in the African Region and 75% for the Region of the Americas and Europe. Most of the 22 HBCs have reached or exceeded a treatment success rate of 85%. Among the 22 HBCs Ethiopia is the one with rates of treatment success for all new and relapse cases in 2013 that were 89% [
According to the WHO treatment guideline the essential anti-TB drugs are Isoniazid, Rifampicin, Pyrazinamide, Ethambutol, and Streptomycin. All anti-TB drugs should be quality assured, and management of anti-TB drugs should be incorporated into the management of other essential medicines by the ministry of health [
Although the implementation of DOTS increases treatment success and decrease transmission of resistant tuberculosis TB kills 5000 people, every day [
There is also a finding that shows the magnitude of TB burden worldwide. A retrospective study was conducted in Turkey in 2008 on the treatment outcomes of pulmonary TB and factors affecting treatment outcomes. The burden of TB in these finding accounts for defaulted treatment 5.1%, dead subjects 2.4%, failure 0.3%, and transfer-out 0.5% of all patients and among smear positive pulmonary TB there were defaulted treatment 5.4%, dead subjects 2.9%, failure 0.4%, and transfer-out 0.7% cases [
According to the 2008 report of WHO, Ethiopia ranks seventh among the world’s 22 countries with a high tuberculosis burden [
Several reasons and risk factors for poor TB treatment outcomes have been reported. High age, male sex, low income, no or limited access to transport, distance from home to the treatment center, incomplete treatment compliance, limited interest in information about the disease and its treatment, limited social support, multidrug resistance, and comorbidity have all been found to be related to unsuccessful treatment outcomes [
It is not clear which factors are major contributors to poor outcome of TB patients in the UoGTH. Therefore, it would be better to look for ways of predicting TB treatment outcome and identifying factors that can help to predict poor treatment outcome which will help to identify those patients that are at a higher risk of poor treatment outcome while being treated with anti-TB drugs. With this information, clinicians could give such patients special attention during their follow-up in order to prevent occurrence of negative consequences following poor treatment outcome. This study will assess the TB treatment outcome and the possible associated factors with treatment outcome among TB patients in UoGTH.
General objective is to assess the treatment outcomes of tuberculosis and associated factors in an Ethiopian University Hospital.
Specific objectives are to assess the outcomes of patients registered for antituberculosis treatment, to identify factors associated with treatment outcomes of tuberculosis.
The study was conducted in University of Gondar Teaching Hospital TB clinic found in Gondar town. The data were collected from March 1 to April 8, 2013.
The source population of the study was all patients registered for treatment of TB at University of Gondar Teaching Hospital from September 1, 2008, to August 31, 2012.
The study population was all tuberculosis patients who had treatment outcome at University of Gondar Teaching Hospital between September 1, 2008, and August 31, 2012: Inclusion criteria were as follows:
Full patient data. New case PTB/EPTB. Retreatment case. Others. Transfer-in. Exclusion criteria were as follows:
TB patients who had two outcomes.
All data were retrieved from records of patient registration who took anti-TB treatment during the period of September 1, 2008, and August 31, 2012.
Dependent variables were as follows:
Tuberculosis treatment outcome. Independent variables were as follows:
Sociodemography:
age, gender, weight. Comorbidity:
TB/HIV coinfections. Tuberculosis type:
smear negative pulmonary TB, smear positive pulmonary TB, extrapulmonary TB. Category of patient:
new case, retreatment case, others, transfer-in.
Data were collected through medical record reviews of patients using a prepared standard checklist in TB clinic. The contents of the checklist include sociodemography, HIV status, types of TB, and treatment outcome. In order to assure the quality of data the following measures will be undertaken.
Data was collected by 4 nurses after giving one-day training for data collectors on the data collection format and techniques of data collection. Supervisor was strictly supervising data collectors daily and the principal investigator was reviewing all filled format.
Data were checked for its completeness every day. To be edited, cleaned, and analyzed, the collected data were entered into a computer using SPSS version 16. A descriptive analysis was conducted to check for outliers and consistencies and to identify missed values for independent variables. Bivariate analysis was employed to see the crude association between each exposure and outcome variables. To control the effect of confounding factors or to get independently associated variables, each of the variables that are statistically significant at
The result of the study will be disseminated to responsible bodies such as Jimma University Department of Pharmacy, Federal Ministry of Health, Ethiopia Food, Medicines and Health Care Administration and Control Authority, Regional Health Bureau, zonal and district health offices, and district administration of the study area. The study finding will also be submitted to professional journal for publication so as to serve as baseline for further studies.
According to the standard definitions of the National Tuberculosis and Leprosy Control Program (NTLCP) guideline adopted from WHO, the following clinical case and treatment outcome definitions will be used.
It refers to the following: a patient with at least two sputum specimens which were positive for acid-fast bacilli (AFB) by microscopy or a patient with only one sputum specimen which was positive for AFB by microscopy, as well as chest radiographic abnormalities consistent with active pulmonary TB.
It refers to the following: a patient with symptoms suggestive of TB with at least two sputum specimens which were negative for AFB by microscopy and with chest radiographic abnormalities consistent with active pulmonary TB (including interstitial or miliary abnormal images) or a patient with two sets of at least two sputum specimens taken at least two weeks apart and which were negative for AFB by microscopy and radiographic abnormalities consistent with pulmonary TB and lack of clinical response to one week of broad spectrum antibiotic therapy.
This included tuberculosis of organs other than the lungs, such as lymph nodes, abdomen, genitourinary tract, skin, joints and bones, and meninges. Diagnosis of EPTB was based on fine needle aspiration cytology or biochemical analyses of cerebrospinal/pleural/ascitic fluid or histopathological examination or strong clinical evidence consistent with active extrapulmonary tuberculosis, followed by a decision of a clinician to treat with a full course of antituberculosis chemotherapy. In all the cases of EPTB, sputum examinations and chest radiographs were used to investigate the involvement of lung parenchyma.
A case of TB is a patient in whom tuberculosis has been confirmed bacteriologically or diagnosed by a clinician. The following are case definitions:
The treatment outcome was divided into seven categories according to NTLCP guideline. These categories were as follows:
However, patients who transferred out to other districts were excluded from the treatment outcome evaluation as information on their treatment outcome was unavailable.
In line with WHO criteria, treatment outcomes were categorized into the following:
Out of 1584 patients who had known outcome between January 2008 and December 2012 at University of Gondar Teaching Hospital, 882 (55.7%) were males and their mean age was 28.3 (SD ± 1.47) years (Table
Sociodemographic characteristics of all TB patients in UoGTH, 2008–2012.
Characteristics | Frequency | Percent |
---|---|---|
Age (years) | ||
<15 | 211 | 13.3 |
≥15 | 1373 | 86.7 |
|
|
|
Sex | ||
Male | 882 | 55.7 |
Female | 702 | 44.3 |
|
|
|
Weight (kg) | ||
0–4.9 | 14 | 0.9 |
5–7.9 | 31 | 2.0 |
8–14.9 | 60 | 3.8 |
15–19.9 | 35 | 2.2 |
20–29.9 | 65 | 4.1 |
30–39.9 | 216 | 13.6 |
40–54.9 | 831 | 52.2 |
55–70.9 | 238 | 15.0 |
≥71 | 16 | 1.0 |
Unknown | 78 | 4.9 |
|
|
|
Among patients for whom disease categories were documented 303 (19.1%) were smear positive pulmonary TB and 844 (53.3%) were smear negative pulmonary TB. Categories of patients were also documented for all types of TB; of these 1307 (82.5%) were classified as new cases. With regard to HIV status, 212 (13.4%) were positive and, of those HIV positive, 54 (25.5%) and 45 (21.2%) initiated CPT (Cotrimoxazole Preventive Treatment) and ART (Antiretroviral Treatment), respectively. Concerning smear result, 32 (10.6%) were positive at the second month (Table
Clinical characteristics of all TB patients in UoGTH, 2008–2012.
Characteristics | Frequency | Percent |
---|---|---|
Tuberculosis type | ||
Smear positive | 303 | 19.1 |
Smear negative | 844 | 53.3 |
Extrapulmonary | 437 | 27.6 |
|
|
|
Category of patients | ||
New | 1307 | 82.5 |
Retreatment | 41 | 2.6 |
Others | 89 | 5.6 |
Transfer-in | 147 | 9.3 |
|
|
|
HIV status | ||
Positive | 212 | 13.4 |
Negative | 420 | 26.5 |
Unknown | 952 | 60.1 |
|
|
|
CPT initiation for HIV positive TB patients | ||
Yes | 54 | 25.5 |
No | 158 | 74.5 |
|
|
|
ART initiation for HIV positive TB patients | ||
Yes | 45 | 21.2 |
No | 167 | 78.8 |
|
|
|
Smear result at 2nd month for PTB +ve patients | ||
Positive | 32 | 10.6 |
Negative | 207 | 68.3 |
Not tested | 64 | 21.1 |
|
|
|
Smear result at 5th month for PTB +ve patients | ||
Positive | 5 | 1.7 |
Negative | 221 | 72.9 |
Not tested | 77 | 25.4 |
|
|
|
Smear result at 7th month for PTB +ve patients | ||
Positive | 3 | 1.0 |
Negative | 218 | 71.9 |
Not tested | 82 | 27.1 |
|
|
|
Among all TB patients enrolled in this study 735 (46.4%) completed treatment, 338 (21.3%) defaulted, 281 (17.7%) died, 217 (13.7%) were cured, 13 (0.8%) had treatment failure (Table
Outcomes of all TB patients by age, sex, and year of registration in UoGTH.
Characteristics | Total ( |
Cured | Treatment completed | Death | Failure | Default |
---|---|---|---|---|---|---|
Age (years) | ||||||
<15 | 211 | 2 | 125 | 14 | 0 | 70 |
≥15 | 1373 | 215 | 610 | 267 | 13 | 268 |
Sex | ||||||
Male | 882 | 119 | 415 | 158 | 6 | 184 |
Female | 702 | 98 | 320 | 123 | 7 | 154 |
Year of registration | ||||||
2008 | 419 | 69 | 173 | 97 | 7 | 73 |
2009 | 348 | 49 | 161 | 61 | 1 | 76 |
2010 | 285 | 33 | 138 | 47 | 2 | 65 |
2011 | 296 | 35 | 124 | 44 | 3 | 90 |
2012 | 236 | 31 | 139 | 32 | 0 | 34 |
Multivariable logistic regression analysis and factors associated with unsuccessful treatment outcome in all types of TB patients in UoGTH, 2008–2012.
Characteristics | Successful treatment outcome |
Unsuccessful treatment outcome |
AOR (95% CI) |
|
---|---|---|---|---|
Weight (kg) | ||||
0–4.9 | 4 (28.6) | 10 (71.4) | 2.826 (0.868–9.196) | 0.084 |
5–7.9 | 12 (38.7) | 19 (61.3) | 1.909 (0.901–4.047) | 0.092 |
8–14.9 | 36 (60) | 24 (40) | 0.830 (0.480–1.437) | 0.507 |
15–19.9 | 23 (65.7) | 12 (34.3) | 0.605 (0.294–1.245) | 0.172 |
20–29.9 | 42 (64.6) | 23 (35.4) | 0.695 (0.403–1.198) | 0.191 |
30–39.9 | 104 (48.1) | 112 (51.9) |
|
|
40–54.9 | 491 (59.1) | 340 (40.9) | 1 | |
55–70.9 | 168 (70.6) | 70 (29.4) |
|
|
≥71 | 14 (87.5) | 2 (12.5) |
|
|
Unknown | 58 (74.4) | 20 (25.6) | 1.204 (0.573–2.532) | 0.624 |
Tuberculosis type | ||||
Smear positive | 224 (73.9) | 79 (26.1) | 1 | |
Smear negative | 469 (55.6) | 375 (44.4) |
|
|
Extrapulmonary | 259 (59.3) | 178 (40.7) |
|
|
Category of patients | ||||
New | 772 (59.1) | 535 (40.9) | 1 | |
Retreatment | 13 (31.7) | 28 (68.3) |
|
|
Others | 54 (60) | 36 (40) | 0.841 (0.536–1.319) | 0.451 |
Transfer-in | 113 (77.4) | 33 (22.6) |
|
|
HIV status | ||||
Positive | 105 (49.5) | 107 (50.5) |
|
|
Negative | 288 (68.6) | 132 (31.4) | 1 | |
Not tested | 559 (58.7) | 393 (41.3) |
|
|
AOR = Adjusted Odds Ratio and 1 indicates reference.
Logistic regression analysis was done for all characteristics. In the final multivariable logistic model, unsuccessful treatment outcome varied by weight, tuberculosis type, category of patients, and HIV status (Table
The probability of developing unsuccessful treatment outcome was 1.508 (95% CI: 1.102–2.065) times higher among weight category 30–39.9 kg compared to 40–54.9 kg. Those with weight categories 50–70.9 kg of TB patients were less likely to experience (AOR = 0.573, 95% CI: 0.415–0.790) unsuccessful treatment outcome compared to those with weight categories of 40–54.9 kg. Successful treatment outcomes were documented in weight category ≥71 kg compared to weight category 40–54.9 kg (AOR = 0.199, 95% CI: 0.044–0.897). Patients who were being treated for smear negative PTB had 3.204 (95% CI: 2.277–4.509) times the unsuccessful treatment outcome compared to patients being treated for smear positive PTB. A type of TB documented as EPTB had also 3.175 (95% CI: 2.201–4.581) times higher probability of unsuccessful treatment outcome compared to smear positive PTB. The likelihood of unsuccessful treatment outcome was more frequent (AOR = 6.733, 95% CI: 3.235–14.013) in retreatment than in newly treated cases. Transfer-in patients were less likely to experience (AOR = 0.380, 95% CI: 0.214–0.673) unsuccessful treatment outcome when compared to those newly treated. Patients who were being treated for HIV positive TB had unsuccessful treatment outcome compared to patients being treated for HIV negative TB (AOR = 1.988, 95% CI: 1.393–2.838). The probability of developing unsuccessful treatment outcome was 1.506 (95% CI: 1.166–1.945) times higher among TB patients with nontested HIV status compared to HIV negative TB patients (Table
Assessment of antituberculosis treatment outcome as well as analysis of factors responsible for poor treatment outcome is one of the major indicators for the evaluation of the performance of a national TB program. In this study, the successful treatment outcomes of all TB types were 60.1% which is lower than the NTLCP and WHO target of 85% and in addition lower than the studies conducted in some parts of Ethiopia including 74.8% in Southern Region [
In this finding successful outcome increases from the previous 29.5% to 60.1% and this could be due to the exclusion of transfer-out patient, because large number of transfer-out patients could compromise the treatment success rate, as this group is often included in the denominator. Here the feedback system is poor and there are no mechanisms to confirm whether these patients registered to continue treatment in other centers. The other possible reason for the increment of successful treatment outcome in UoGTH compared to the previous study conducted in this university hospital could be the encouragement of DOTS performance.
The unsuccessful treatment outcome of our finding 39.9% is lower when compared to 70.6% of the previous study conducted in UoGTH [
In multivariable logistic regression the unsuccessful treatment outcomes of our finding were significantly higher in weight category 30–39.9 kg and smear negative PTB and EPTB and retreatment cases and seropositive TB patients and unknown serostatus TB patients but lower in weight categories 55–70.9 kg and ≥71 kg and transfer-in patients.
In this study weight of the patient during initiation of anti-TB treatment (30–39.9 kg) was significantly associated with unsuccessful treatment outcome but weight category of 55–70.9 kg and ≥71 kg during initiation of anti-TB treatment was significantly associated with successful treatment outcome. One study in Addis Ababa revealed that body weight at initiation of anti-TB treatment (<35 kg) was a significant risk factor of death during antituberculosis treatment period [
In this observation tuberculosis type was associated with unsuccessful treatment outcome. The characteristics of TB patients associated with unsuccessful treatment outcome during anti-TB treatment were being smeared negative pulmonary TB and extrapulmonary TB [
The finding of this study showed that treatment category was associated with unsuccessful treatment outcome especially for patients who were treated previously. One study stated that undergoing retreatment was found to be a significant risk factor for unsuccessful treatment outcome [
Regarding comorbidity our study showed that HIV positive TB patients have an increased risk of unsuccessful treatment outcome compared to HIV negative TB patients. Similarly one study showed that TB/HIV coinfection was significantly associated with unsuccessful treatment outcome [
High proportion of unsuccessful treatment outcome was documented in this study. Moreover, the following risk factors were identified as predictors of unsuccessful treatment outcome: body weight at initiation of anti-TB treatment (30–39.9 kg), smear negative PTB, EPTB, retreatment cases, HIV positive TB patients, and unknown HIV status TB patients. Based on the findings of this study, we recommend that emphasis has to be given for patients with high risk of unsuccessful treatment outcome and targeted interventions should be carried out. Furthermore the fate of transfer-out patients is not known; therefore we recommend further study on these patients.
Letter of ethical clearance was obtained from Research Ethics Committee of Jimma University. The patient data were accessed upon the approval of clinical director of UoGTH. Confidentiality was ensured during the data collection; thus name and address of the patient were not recorded in the data collection checklist.
The authors declare that they have no competing interests.