Investigator(s)
| Submitter |
Chime Dema Gidakom Hospital Chime Dema 
|
| Principal Investigator |
Pema wangchuk Gidakom Hospital Pema wangchuk
|
| Co-Investigator(s) |
Sonam Choki Gidakom hospital Sonam Choki
|
| Co-Investigator(s) |
Tshewang dema gidakom hospital Tshewang dema
|
| Co-Investigator(s) |
Laxmi Prasad Dahal Gidakom hospital Laxmi Prasad Dahal
|
| Co-Investigator(s) |
Chimi Thinley dorji gidakom hospital Chimi Thinley dorji
|
Title(s) and abstract
| Scientific title | Retrospective cohort study on Epidemiology, risk factors and response to treatment among MDR-TB patients at a treatment center in Western Bhutan. |
| Public title | Epidemiology, risk factors and response to treatment among MDR-TB patients at a treatment center in Western Bhutan. |
| Background | Drug-resistant Tuberculosis (DR-TB) continues to pose a significant global public health threat, undermining the progress achieved by the World Health Organization (WHO) in the fight to end tuberculosis (WHO, 2019). Bhutan also faces a significant burden of DR-TB (MOH, 2024). In response, WHO has issued a series of evidence-based policy recommendations for the effective management of DR-TB (WHO, 2020). In Bhutan, the national tuberculosis control program initiated the programmatic management of drug resistant TB in 2010 and the first national guideline for management of DR-TB was developed in 2011. It was revised in subsequent years in accordance with the updated WHO guidelines for management of DR-TB using new diagnostic tools and treatment regimen (Parmar,2019, MOH, 2017). The most recent guidelines, released in 2022, recommend shorter, all-oral treatment regimens such as BPAL, BPALM, and the 9-month all-oral regimen, which were adopted in Bhutan starting in June 2024 (WHO, 2022). However, DR-TB still remains a public health challenge worldwide as well as in Bhutan with multiple risk factors associated in its development (Li et al., 2015). |
| Objectives | 1. To identify and analyses sociodemographic, behavioral, and clinical risk factors associated with MDR-TB. 2. To determine the prevalence and pattern of alcohol use among patients admitted for MDR-TB treatment in Gidakom Hospital from June 2024 to July 2025. 3. To assess the association between alcohol use and risk of MDR-TB infection. 4. To assess the type, frequency, and severity of ADRs related to the shorter MDR-TB treatment regimen including BPaLM among MDR-TB patients. |
| Study Methods | This study will use restrospective study design to assess the risk factors associated with multidrug-resistant tuberculosis (MDR-TB). The research will be conducted at Gidakom General Hospital, a designated MDR-TB treatment center in Western Bhutan. All MDR-TB patients admitted between June 2024 till July 2025 will be included. Data will be extracted from existing hospital records, including electronic Patient Information System (ePIS), physical medical records, MDR-TB registers, adverse drug reaction (ADR) forms, and nursing assessment sheets. Descriptive statistics will be used to analyze and summarize the dataset. Continuous variables will be assessed for normality using the Shapiro-Wilk test and histograms. Univariate analyses (Chi-square/Fisher’s exact tests for categorical and t-tests/Mann-Whitney U for continuous variables) will identify potential risk factors. Variables with a p-value < 0.25 in univariate analysis will be entered into a multivariate logistic regression model, using backward stepwise selection to identify independent risk factors (p < 0.05).. All data will be pseudonymised and handled in compliance with the Health Information Privacy and Security Act of Bhutan 2011. Ethical clearance will be obtained from the Research Ethics Board of Health (REBH) and administrative approvals will be secured prior to data collection. |
| Expected outcomes and use of results | This study will identify the main risk factors associated with MDR-TB patients in Gidakom hospital (a tertiary MDR-TB treatment center) in Bhutan from 2020-2025 by retrospective analysis of patient records and determine the prevalence of alcohol use among the same cohort. It will also evaluate the adverse effects of BPaLM regimen in MDR-TB patients in Bhutan from July 2024 onward using matched case-control study and assess the severity of adverse effects of BPaLM regimen using WHO recommended grading scales. The findings from this study will be used to provide evidence-based recommendation to policy makers about at-risk populations for MDR-TB based on the identified risk factor and to recommend timely detection and management of adverse effects. |
| Keywords | MDR-TB in Bhutan, RR -TB, risk factors associated with MDR-TB, BPALM, |
Research Details
| Student research | No |
| Start Date | 01-Jul-2025 |
| End Date | 01-Jan-2026 |
| Key Implementing Institution | Ministry of Health |
| Multi-country research | No |
| Nationwide research | No |
| Bhutan | |
| Research Domain(s) | Communicable Disease Research |
| Research field(s) | Tuberculosis |
| Involves human subjects | Yes |
| Qualitative Study | |
| Data Collection | Secondary data |
| Proposal reviewed by other Committee | No |