Research Article | Open Access
Treatment outcomes and risk factors associated with unsuccessful treatment outcomes among extra pulmonary tuberculosis patients
Abdul Wahid1, Rehana Salam1, Urosa Bashir1, Nighat Nawaz1, Fareeha Iqbal1, Asad Khan1, Ghulam Mustafa Shahwani2, Abdul Ghafar3, Wajeeha Sadique1
1Department of Pharmacy Practice, Faculty of Pharmacy and Health Sciences, University of Balochistan, Quetta, Pakistan.
2Department of Pharmaceutics, Faculty of Pharmacy and Health Sciences, University of Balochistan, Quetta, Pakistan.
3Department of Pharmacology, Faculty of Pharmacy and Health Sciences, University of Balochistan, Quetta, Pakistan.
Correspondence: Abdul Wahid (Department of Pharmacy Practice, Faculty of Pharmacy and Health Sciences, University of Balochistan, Quetta, Pakistan; E-mail: wahiduob@gmail.com).
Asia-Pacific Journal of Pharmacotherapy & Toxicology 2023, 3: 16-22. https://doi.org/10.32948/ajpt.2023.12.27
Received: 23 Oct 2023 | Accepted: 29 Nov 2023 | Published online: 29 Dec 2023
Methods This study was retrospective cohort study, the study included 320 EPTB patients who were registered and treated at BMCH Quetta, Balochistan, from January 1, 2021 to June 30, 2021. SPSS version 21 was used to analyze the data, and a p-value 0.05 was used to determine statistical significance.
Results The treatment had a success rate of 74.4% overall, with 12.4% of the patients LTFU, 5.6% died, and 2.4% failed the treatment. Age older than 60 years (OR = 10.440, p = 0.000) and having meningeal tuberculosis (OR = 3.506, p = 0.008) were found to be predictors for unsuccessful treatment outcomes.
Conclusion The success rate of EPTB did not meet the End TB Strategy’s goal of >90%, as set by the World Health Organization. Therefore, elderly patients and those with meningeal tuberculosis need special attention to improve treatment outcomes.
Key words extra pulmonary TB, TB-high burden country, risk factors, Pakistan
In 2021, TB had a significant global impact, affecting approximately 10.6 million individuals and causing 1.6 million deaths. Among these cases, 6.4 million were either new or recurring instances, with about 17% of them classified as EPTB, where the infection spreads to other organs. The prevalence of EPTB varies across different regions. In Africa, it is 13%, in the Americas 14%, in South-East Asia 21%, in Europe 16%, in the Eastern Mediterranean 23%, and in the Western Pacific, it was 8% [1].
Pakistan holds the fifth position among high burden TB nations, contributing to 5.8% of the global TB cases [2]. Additionally, Pakistan bears a significant load of EPTB cases, constituting 20% of the entire reported TB cases form the country [3, 4]. The diagnosis and treatment of EPTB can present challenges owing to the non-specific symptoms like fever, night sweats weight loss, and malaise as well as organ-specific manifestations [5]. Despite these challenges, both PTB and EPTB are treated with the same standard regimen. The treatment regimen contains four drugs isoniazid, ethambutol, rifampicin, and pyrazinamide for the initial two months, and treated with isoniazid and rifampicin for the next four months [6, 7]. To combat TB effectively, the WHO aims for a treatment success rate of over 90% for EPTB as part of its end TB strategy. However, different countries have reported varying treatment outcomes, ranging from low rates of 52.3- 80.5% [4, 8-12] to higher rates of 90.0-90.5% [13, 14].
Different factors have been associated with PTB, such as male gender, younger age, immunosuppressant, and HIV infection [15-17]. While some other studies have reported female gender and older age to EPTB [18-20]. Diabetes has also been reported as a risk factor associated with unsuccessful treatment outcomes in PTB and EPTB cases [13, 21].
Pakistan has reported an impressive 93% treatment success rate for all types of TB [1]. However, when it comes to EPTB, there is limited research on treatment outcomes and associated risk factors in Pakistan. Some studies conducted in the country have revealed varying EPTB treatment success rates, ranging from 60-90% [3, 4, 11, 22, 23]. The current study aims to investigate the clinical types of EPTB, treatment outcomes, and find out the risk factors associated with unsuccessful treatment among EPTB patients registered at Bolan Medical Complex Hospital (BMCH) in Quetta, Balochistan, Pakistan. The current study can help to enhance the understanding and management of EPTB in the region.
The current study was a record based observational study. This study was conducted at BMCH Quetta, which is a leading tertiary care hospital serving a large population in the city and the entire province, as well as patients from Afghanistan and Iran. The study included all the records of EPTB patients who were registered at BMCH from January 1, 2021, to June 30, 2021. The treatment outcomes of these patients were known until December 31, 2021.
Data Collection
The data was collected by using data collection form which was purposely designed for this study was used. The socio-demographic, clinical and microbiological data was collected from the TB patient files. The data had different important factors including patients' age, gender, place of residence, district, presenting signs and symptoms, co-morbidities, site of TB infection, previous TB history, treatment category, body weight, and treatment outcomes. Unsuccessful treatment outcomes were assessed based on the standard guidelines defined by the World Health Organization (WHO) and the National Tuberculosis Program (NTP). These outcomes were considered unsuccessful if patients experienced death, treatment failure, or loss of follow-up during the treatment period. Following these guidelines, the study aimed to gain insights into the clinical manifestations of EPTB, treatment outcomes, and associated risk factors for unsuccessful treatment among EPTB patients at Bolan Medical Complex Hospital (BMCH) in Quetta, Balochistan, Pakistan.
Statistical Analysis
We used the Statistical Package for the Social Sciences (SPSS) version 21 to analyze the data. We presented categorical variables as frequencies and percentages, and for continuous variables, we reported the mean and standard deviations, where applicable.
We conducted multivariate binary logistic regression (MVBLR) to identify the risk factors associated with unsuccessful treatment outcomes. This statistical technique helped us assess the relationship between multiple independent variables and the binary outcome variable of treatment success or failure for patients with EPTB.
All the independent variables that showed a p-value of 0.2 or less in the univariate analysis were included in the MVBLR. Univariate analysis involved examining each independent variable separately against the outcome variable without considering the effects of other variables. By using a threshold of p≤0.2, we made sure that potentially relevant variables were considered for further investigation in the multivariate analysis. If the p-value for an independent variable in the MVBLR was less than 0.05, it was considered to have a statistically significant association with unsuccessful treatment outcomes of EPTB patients.
Socio-demographic and clinical characteristics
The baseline socio-demographic and clinical characteristics of the patients are presented in table 1. In the current study 51.2% were female, 77.2% of the patients were classified as new cases, and 48.4% accounted for meningeal TB, indicating that this form of EPTB was prevalent among the patients (Table 1).
Treatment Outcomes
The treatment outcomes of the 250 patients were evaluated, Out of these, 186 patients (74.4%) completed the treatment and were categorized as successful treatment outcome. However, 12.4% of patients were lost to follow-up, 5.6% died, and 2.4% were treatment failure. LTFU, death and treatment failure were collectively termed as unsuccessful treatment outcomes. While 5.2% of patients were not evaluated during the course of treatment (Table 2).
Risk factors associated with unsuccessful treatment outcomes
To find the risk factors univariate and multivariate binary logistic regression analysis was performed, patients aged >60 years (OR=5.807, p-value=0.000), patients diagnosed with meningeal TB (OR=2.429, p-value=0.007), had statistically significant association. Furthermore all those variable which had a p-value less than 0.2 were entered to MVBLR analysis. The results from the MVBLR analysis confirmed that patients >60 years (OR=10.440, p-value=0.000) and patients diagnosed with meningeal TB (OR=3.506, p-value=0.008) continued to show a statistically significant association with unsuccessful treatment outcomes as shown in Table 3. The model fit was based on a Hosmer-Lemeshow test that was not significant (p-value=0.530) and an overall classification table percentage of 74.4%.
|
Table 1. Base line Sociodemographic and clinical characteristics of EPTB patients. |
|||
|
Characteristics |
Patients (N) |
Percentages (%) |
|
|
Gender |
Male |
122 |
48.8 |
|
Female |
128 |
51.2 |
|
|
Age groups (Years) |
<14 |
90 |
36.0 |
|
15-30 |
68 |
27.2 |
|
|
31-44 |
28 |
11.2 |
|
|
45-60 |
35 |
14.0 |
|
|
>60 |
29 |
11.6 |
|
|
Site of TB |
Meningeal |
121 |
48.4 |
|
Abdominal |
59 |
23.6 |
|
|
Pleural |
25 |
10.0 |
|
|
Spinal |
18 |
7.2 |
|
|
Lymphatic |
13 |
5.2 |
|
|
Bone/ Joints |
10 |
4.0 |
|
|
Other |
4 |
1.6 |
|
|
Registration |
New |
193 |
77.2 |
|
Failure |
12 |
4.8 |
|
|
Relapse |
18 |
7.2 |
|
|
Unknown Previous History |
27 |
10.8 |
|
|
Weight Category (Kgs) |
<30 |
85 |
34.0 |
|
31-60 |
119 |
47.6 |
|
|
>60 |
46 |
18.4 |
|
|
Table 2. Treatment outcomes of EPTB patients. |
|||||
|
Site of TB |
Completed No. (%) |
LTFU No. (%) |
Death No. (%) |
Failure No. (%) |
Not evaluated No. (%) |
|
Meningeal
|
84 (69.4)
|
21 (17.4)
|
10 (8.3)
|
3 (2.5)
|
3 (2.5)
|
|
Abdominal |
48 (81.4)
|
5 (8.5)
|
0 (0.0)
|
2 (3.4)
|
4 (6.8)
|
|
Pleural
|
15 (60.0)
|
1 (4.0)
|
3 (12.0)
|
1 (4.0)
|
5 (20.0)
|
|
Spinal
|
16 (88.9)
|
1 (5.6)
|
1 (5.6)
|
0 (0.0)
|
0 (0.0)
|
|
Lymphatic
|
11 (84.6)
|
2 (15.4)
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
|
Bone/ Joints
|
9 (90.0)
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
1 (10.0)
|
|
Other |
3 (75.0) |
1 (25.0) |
0 (0.0)
|
0 (0.0) |
0 (0.0) |
|
Total (N=250) |
186 (74.4) |
31 (12.4) |
14 (5.6) |
6 (2.4) |
13 (5.2) |
|
Table 3. Univariate and multivariate analysis of EPTB patients. |
|||||||
|
Variable |
Unsuccessful outcome
|
Multivariate analysis |
Multivariate analysis |
||||
|
No, No. (%) |
Yes, No. (%) |
OR (95%CI) |
p-value |
OR (95%CI) |
p-value |
||
|
Gender |
Female |
96 (82.1) |
21 (17.9) |
1 |
- |
1 |
- |
|
Male |
90 (75.0) |
30 (25.0) |
1.524 (0.814-2.854) |
0.188 |
1.177 (0.590-2.347) |
0.644 |
|
|
Age groups (Years) |
<14 |
73 (82.0) |
16 (18.0) |
1 |
- |
1 |
- |
|
15-30 |
50 (78.1) |
14 (21.9) |
1.278 (0.573-2.850) |
0.550 |
1.229 (0.528-2.858) |
0.633 |
|
|
31-44 |
26 (92.9) |
2 (7.1) |
0.351 (0.075-1.632) |
0.182 |
0.386 (0.079-1.877) |
0.238 |
|
|
45-60 |
26 (83.9) |
5 (16.1) |
0.877 (0.292-2.634) |
0.816 |
1.169 (0.370-3.692) |
0.790 |
|
|
>60 |
11 (44.0) |
14 (56.0) |
5.807 (2.230-15.124) |
0.000 |
10.440 (3.511-31.047) |
0.000 |
|
|
Site of TB
|
Meningeal(NO) |
102 (85.7) |
17 (14.3) |
1 |
- |
1 |
- |
|
Meningeal(YES) |
84 (71.2) |
34 (28.8) |
2.429 (1.268-4.651) |
0.007 |
3.506 (1.378-8.924) |
0.008 |
|
|
Abdominal (NO) |
138 (75.8) |
44 (24.2) |
1 |
- |
1 |
- |
|
|
Abdominal (YES) |
48 (87.3) |
7 (12.7) |
0.457 (0.193-1.084) |
0.075 |
1.073 (0.335-3.440) |
0.906 |
|
|
Pleural(NO) |
171 (78.8) |
465 (21.2) |
1 |
- |
- |
- |
|
|
Pleural(YES) |
15 (75.0) |
5 (25.0) |
1.239 (0.428-3.588) |
0.693 |
- |
- |
|
|
Spinal(NO) |
170 (77.6) |
49 (22.4) |
1 |
- |
- |
- |
|
|
Spinal(YES) |
16 (88.9) |
2 (11.1) |
0.434 (0.096-1.951) |
0.276 |
- |
- |
|
|
Lymphatic(NO) |
175 (78.1) |
49 (21.9) |
1 |
- |
- |
- |
|
|
Lymphatic(YES) |
11 (84.6) |
2 (15.4) |
0.649 (0.139-3.028) |
0.583 |
- |
- |
|
|
Bone/ Joints(NO) |
177 (77.6) |
51 (22.4) |
1 |
- |
- |
- |
|
|
Bone/ Joints(YES) |
9 (100.0) |
0 (0.0) |
0.0(0.000) |
0.999 |
- |
- |
|
|
Other(NO) |
183 (78.5) |
50 (21.5) |
1 |
- |
- |
- |
|
|
Other(YES) |
3 (75.0) |
1 (25.0) |
1.220 (0.124-11.984) |
0.865 |
- |
- |
|
|
Registration |
New |
140 (76.9) |
42 (23.1) |
1 |
- |
- |
- |
|
Failure |
9 (81.8) |
2 (18.2) |
0.741 (0.154-3.562) |
0.708 |
- |
- |
|
|
Relapse |
15 (83.3) |
3 (16.7) |
0.667 (0.184-2.414) |
0.537 |
- |
- |
|
|
Unknown |
22 (84.6) |
4 (15.4) |
0.606 (0.198-1.857) |
0.381 |
- |
- |
|
|
Weight Category (Kgs) |
<30 |
67 (80.7) |
16 (19.3) |
1 |
- |
- |
- |
|
31-60 |
84 (77.1) |
25 (22.9) |
1.246 (0.616-2.522) |
0.540 |
- |
- |
|
|
>60 |
35 (77.8) |
10 (22.2) |
1.196 (0.492-2.912) |
0.693 |
- |
- |
|
|
CI: Confidence interval, EPTB: Extra pulmonary tuberculosis, Kgs: Kilo grams, OR: Odds Ratio. |
|||||||
The study found that the rate of LTFU among EPTB patients was concerning, standing at 12.4%. This finding aligns with the results of similar studies conducted elsewhere [26-29]. The high rate of LTFU could be attributed to various reasons, including treatment failure, drug resistance, and unfortunately, deaths of some patients. Additionally, several reasons may contribute to this issue, such as the long duration of treatment, boredom or fatigue with taking medications over an extended period, a false sense of improvement after a certain time, a lack of knowledge about the disease, and poor communication between patients and healthcare workers [28, 30].
Identifying and addressing these risk factors are essential steps towards improving the success rate of treatment among TB patients, especially for those with EPTB. By tackling these underlying challenges, healthcare providers can enhance patient adherence to treatment protocols and reduce the occurrence of LTFU.
In the current study it was found that meningeal TB as the most prevalent type of EPTB, 48.4%, Abdominal TB 23.6%, and pleural TB at 10.0%. These findings align with similar studies conducted elsewhere [31-33].
In multivariate analysis those patients who were aged >60 were more prone to develop unsuccessful treatment outcomes incompliance to our study some other studies have also found older age as risk factor for unsuccessful treatment outcomes [12, 34]. Patients aged >60 may have more chance to develop unsuccessful treatment outcomes due to many factors. These include weakened immunity associated with aging, the presence of concurrent co-morbidities, complexities in managing multiple medications, and difficulties in regularly visiting treatment facilities [35, 36]. Additionally, older patients might face challenges in adhering to treatment regimens due to factors such as mobility limitations, cognitive impairments, or social support constraints.
By acknowledging and understanding the factors that influence treatment outcomes, healthcare systems can develop specific strategies to improve the care and management of EPTB patients, particularly in high-risk groups such as the elderly.
Furthermore, among the different types of EPTB, meningeal TB was likely to develop unsuccessful treatment outcomes. This could be because of the longer treatment duration required for meningeal TB. The penetration of ethambutol and rifampicin into the cerebrospinal fluid is poor, which might lead to patients discontinuing treatment prematurely or being unaware of the importance of completing the treatment [37-39]. The mortality rate among patients with meningeal TB in this study was 17.4%, and the loss to follow-up rate was 8.3%, which was higher than other types of EPTB. Other studies from the United States, Iran, and Pakistan have also reported meningeal TB as a significant risk factor for unfavorable treatment outcomes [4, 40, 41].
The current findings cannot be generalized to the entire province or country. However some medical records of patients were incomplete so it was not feasible to capture a number of crucial variables that could have influenced the treatment outcome. The study revealed that the rate of treatment success among EPTB patients fell short of the TB End Treatment Strategy's goal, requiring immediate attention. In addition, future research should highlight the causes of LTFU.
We thank the dean, Faculty of Pharmacy and Health Sciences University of Balochistan and the Medical Superintendent of BMC Hospital for their support during this research.
Ethics approval
The study followed ethical guidelines and obtained proper approval before conducting the research. The ethical approval was granted by the Research and Ethics Committee of the Faculty of Pharmacy and Health Sciences at the University of Balochistan, Quetta. Additionally, the study was authorized by the Medical Superintendent BMC hospital.
Data availability
The Data will be available upon request.
Funding
The authors did not receive any funding or support to report.
Authors’ contribution
Abdul Wahid conceptualized and supervised the study, while Rehana Salam, Urosa Bashir, Nighat Nawaz, and Fareeha Iqbal collected and entered the data. Asad Khan and Ghulam Mustafa Shahwani analyzed the data, and Abdul Ghafar and Wajeeha Sadique critically reviewed it.
Competing interests
The authors have reported no conflicts of interest.
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