scholarly journals ”Side effects--part of the package”: A mixed methods approach to adverse events among patients being programmatically treated for DR-TB in Gujarat, India

2020 ◽  
Author(s):  
Arjunkumar Hardas Jakasania ◽  
Kalpita shringarpure ◽  
Dixit Kapadia ◽  
Radhika Sharma ◽  
Kedar Mehta ◽  
...  

Abstract Background Unsuccessful treatment outcomes among patients with drug resistant tuberculosis (DR-TB) are due to high rates of adverse events (AEs). However, information related to AEs is not systematically collected and managed under programmatic setting. The present study assessed the a) incidence and pattern of adverse events in first three months of DR-TB treatment initiation; b) treatment seeking behaviour for AE management; and c) explore the challenges in seeking treatment and reporting AEs.Methods This mixed methods study included all patients diagnosed and initiated on treatment under RNTCP during July-September 2018 at Ahmedabad DR-TB centre. The patients were interviewed telephonically and assessed for all AEs experienced by them. In-depth interviews and key-informant interviews were conducted among patients, DOTS supervisors and programme staffs (treatment supervisors, medical officer and district program manager). Results Total 207 AEs were reported by the 74 DR-TB patients. All patients experienced at least one AE during initial treatment period. Incidence rate of AEs (experienced) was 3.11 (1st month-4.6, 2nd month-2.7, 3rd month-2.02) per 100 person days. Of the 207 AEs, gastro-intestinal (59, 28.3%), ophthalmic (32, 15.4%) and otolaryngology (25, 11.9%) system related AEs were commonly experienced. Treatment was not sought in two-fifths of the AEs. Themes and sub-themes related to challenges in treatment seeking or reporting of AEs were 1) Patient related-Misconceptions, accessibility and affordability of management, lack of counselling support, stigma and discrimination, and past treatment experience; 2) Health system related- lack of guidelines and training for AE management, 3) Poor coordination between hospital and tuberculosis centre. Conclusion The incidence of AEs was high among patients with DR-TB in the first three months of treatment and treatment seeking/reporting was low. Adequate health education and counselling of the patient and orientation of the health systems are the need of the hour. An efficient real-time reporting and management of AE can be developed and tested for effective DR-TB control.

2019 ◽  
Author(s):  
Arjunkumar Hardas Jakasania ◽  
Kalpita Shringarpure ◽  
Dixit Kapadia ◽  
Radhika Sharma ◽  
Kedar Mehta ◽  
...  

Abstract Background: Unsuccessful treatment outcomes among patients with drug resistant tuberculosis (DR-TB) are due to high rates of adverse events (AEs). However, information related to AEs is not systematically collected and managed under programmatic setting. The present study assessed the a) incidence and pattern of adverse events in first three months of DR-TB treatment initiation; b) treatment seeking behaviour for AE management; and c) explore the challenges in seeking treatment and reporting AEs. Methods: This mixed methods study included all patients diagnosed and initiated on treatment under RNTCP during July-September 2018 at Ahmedabad DR-TB centre. The patients were interviewed telephonically and assessed for all AEs experienced by them. In-depth interviews and key-informant interviews were conducted among patients, DOTS supervisors and programme staffs (treatment supervisors, medical officer and district program manager). Results: A total 207 AEs were reported by the 74 DR-TB patients. All patients experienced at least one AE during initial treatment period. Incidence rate of AEs (experienced) was 3.11 (1st month-4.6, 2nd month-2.7, 3rd month-2.02) per 100 person days. Of the 207 AEs, gastro-intestinal (59, 28.3%), ophthalmic (32, 15.4%) and otolaryngology (25, 11.9%) system related AEs were commonly experienced. Treatment was not sought in two-fifths of the AEs. Themes and subthemes related to challenges in treatment seeking or reporting of AEs were 1) Patient related-Misconceptions, accessibility and affordability of management, lack of counselling support, stigma and discrimination, and past treatment experience; 2) Health system related- lack of guideline and training for AE management, and poor coordination between hospital and tuberculosis centre. Conclusion: The incidence of AEs was high among patients with DR-TB in the first three months of treatment and treatment seeking/reporting was low. Adequate health education and counselling of the patient and orientation of the health systems are the need of the hour. An efficient real-time reporting and management of AE can be developed and tested for effective DR-TB control.


2020 ◽  
Author(s):  
Arjunkumar Hardas Jakasania ◽  
Kalpita shringarpure ◽  
Dixit Kapadia ◽  
Radhika Sharma ◽  
Kedar Mehta ◽  
...  

Abstract Background High rates of Adverse Events (AEs) during treatment is one of the leading causes of unsuccessful treatment outcomes among patients with drug resistant tuberculosis (DR-TB). However, information related to AEs is not systematically collected and managed under programmatic setting. The present study assessed the a) incidence and pattern of adverse events in first three months of DR-TB treatment initiation; b) treatment seeking behaviour for AE management; and c) explore the challenges in seeking treatment and reporting AEs.Methods This mixed methods study included all patients diagnosed and initiated on treatment under RNTCP during July-September 2018 at Ahmedabad DR-TB centre. The patients were interviewed telephonically and assessed for all AEs experienced by them. In-depth interviews and key-informant interviews were conducted among patients, DOTS supervisors and programme staffs (treatment supervisors, medical officer and district program manager). Results Total 207 AEs were reported by the 74 DR-TB patients. All patients experienced at least one AE during initial treatment period. Incidence rate of AEs (experienced) was 3.11 (1st month-4.6, 2nd month-2.7, 3rd month-2.02) per 100 person days. Of the 207 AEs, gastro-intestinal (59, 28.3%), ophthalmic (32, 15.4%) and otolaryngology (25, 11.9%) system related AEs were commonly experienced. Treatment was not sought in two-fifths of the AEs. Themes and sub-themes related to challenges in treatment seeking or reporting of AEs were 1) Patient related-Misconceptions, accessibility and affordability of management, lack of counselling support, stigma and discrimination, and past treatment experience; 2) Health system related- lack of guidelines and training for AE management, 3) Poor coordination between hospital and tuberculosis centre. Conclusion The incidence of AEs was high among patients with DR-TB in the first three months of treatment and treatment seeking/reporting was low. Adequate health education and counselling of the patient and orientation of the health systems are the need of the hour. An efficient real-time reporting and management of AE should be developed and tested for effective DR-TB control.


2020 ◽  
Author(s):  
Arjunkumar Hardas Jakasania ◽  
Kalpita shringarpure ◽  
Dixit Kapadia ◽  
Radhika Sharma ◽  
Kedar Mehta ◽  
...  

Abstract BackgroundHigh rates of Adverse Events (AEs) during treatment is one of the leading causes of unsuccessful treatment outcomes among patients with drug resistant tuberculosis (DR-TB). However, information related to AEs is not systematically collected and managed under programmatic setting. The present study assessed the a) incidence and pattern of adverse events in first three months of DR-TB treatment initiation; b) treatment seeking behaviour for AE management; and c) explore the challenges in seeking treatment and reporting AEs.MethodsThis mixed methods study included all patients diagnosed and initiated on treatment under RNTCP during July-September 2018 at Ahmedabad DR-TB centre. The patients were interviewed telephonically and assessed for all AEs experienced by them. In-depth interviews and key-informant interviews were conducted among patients, DOTS supervisors and programme staffs (treatment supervisors, medical officer and district program manager). Results: Total 207 AEs were reported by the 74 DR-TB patients. All patients experienced at least one AE during initial treatment period. Incidence rate of AEs (experienced) was 3.11 (1st month-4.6, 2nd month-2.7, 3rd month-2.02) per 100 person days. Of the 207 AEs, gastro-intestinal (59, 28.3%), ophthalmic (32, 15.4%) and otolaryngology (25, 11.9%) system related AEs were commonly experienced. Treatment was not sought in two-fifths of the AEs. Themes and sub-themes related to challenges in treatment seeking or reporting of AEs were 1) Patient related-Misconceptions, accessibility and affordability of management, lack of counselling support, stigma and discrimination, and past treatment experience; 2) Health system related- lack of guidelines and training for AE management, 3) Poor coordination between hospital and tuberculosis centre. Conclusion: The incidence of AEs was high among patients with DR-TB in the first three months of treatment and treatment seeking/reporting was low. Adequate health education and counselling of the patient and orientation of the health systems are the need of the hour. An efficient real-time reporting and management of AE should be developed and tested for effective DR-TB control.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Arjunkumar Jakasania ◽  
Kalpita Shringarpure ◽  
Dixit Kapadia ◽  
Radhika Sharma ◽  
Kedar Mehta ◽  
...  

Abstract Background High rates of Adverse Events (AEs) during treatment is one of the leading causes of unsuccessful treatment outcomes among patients with drug resistant tuberculosis (DR-TB). However, information related to AEs is not systematically collected and managed under programmatic setting. The present study assessed the a) incidence and pattern of adverse events in first three months of DR-TB treatment initiation; b) treatment seeking behaviour for AE management; and c) explore the challenges in seeking treatment and reporting AEs. Methods This mixed methods study included all patients diagnosed and initiated on treatment under RNTCP during July–September 2018 at Ahmedabad DR-TB centre. The patients were interviewed telephonically and assessed for all AEs experienced by them. In-depth interviews and key-informant interviews were conducted among patients, DOTS supervisors and programme staff (treatment supervisors, medical officer and district program managers). Results Total 207 AEs were reported by the 74 DR-TB patients. All patients experienced at least one AE during initial treatment period. Incidence rate of AEs (experienced) was 3.11 (1st month-4.6, 2nd month-2.7, 3rd month-2.02) per 100 person days. Of the 207 AEs, gastro-intestinal (59, 28.3%), ophthalmic (32, 15.4%) and otolaryngology (25, 11.9%) system related AEs were commonly experienced. Treatment was not sought in two-fifths of the AEs. Themes and sub-themes related to challenges in treatment seeking or reporting of AEs were 1) Patient related-Misconceptions, accessibility and affordability of management, lack of counselling support, stigma and discrimination, and past treatment experience; 2) Health system related- lack of guidelines and training for AE management, 3) Poor coordination between hospital and tuberculosis centre. Conclusion The incidence of AEs was high among patients with DR-TB in the first three months of treatment and treatment seeking/reporting was low. Adequate health education and counselling of the patient and orientation of the health systems is the need of the hour. An efficient real-time reporting and management of AE should be developed and tested for effective DR-TB control.


2020 ◽  
Author(s):  
Arjunkumar Hardas Jakasania ◽  
Kalpita shringarpure ◽  
Dixit Kapadia ◽  
Radhika Sharma ◽  
Kedar Mehta ◽  
...  

Abstract Background Unsuccessful treatment outcomes among patients with drug resistant tuberculosis (DR-TB) are associated with poor treatment adherence due to high rates of adverse events (AEs). However, AEs are not systematically collected and managed under programmatic setting. The present study aims to assess the a) incidence and pattern of adverse events in first three months of DR-TB treatment; b) treatment seeking behaviour for AE management; and c) explore the challenges perceived by patients and healthcare providers in seeking treatment/reporting AEs. Methods This mixed methods study included all patients diagnosed and initiated on treatment during July-September 2018 at Ahmedabad DR-TB centre under RNTCP. The patients were interviewed telephonically and assessed for all AEs experienced by them during first three months of DR-TB treatment initiation. In-depth interviews and key-informant interviews were conducted among patients and DOTS supervisors, and programme staff (treatment supervisors, Medical Officer and District Program Manager). Results Total 207 AEs were reported by the 74 DR-TB patients who were interviewed. All patients experienced at least one AE during treatment. Incidence rate of AEs (experienced) was 3.11 (1 st month-4.6, 2 nd month-2.7, 3 rd month-2.02) per 100 person days of the 207 AEs, gastro-intestinal (59, 28.3%), ophthalmic (32, 15.4%) and otolaryngology (25, 11.9%) system related AEs were commonly experienced. Treatment was not sought in two-fifths of the AEs. Themes and subthemes related to challenges in treatment seeking or reporting of AEs were 1) Patient related-Misconceptions, accessibility and affordability of management, lack of counselling support, stigma and discrimination, past treatment experience; 2) Health system related- lack of guideline and training for AE management, poor coordination between hospital and tuberculosis centre.Conclusion The incidence of AEs was high among patients with DR-TB in the first three months of treatment and treatment seeking/reporting was low. Adequate health education and counselling of the patient should be done at initiation of treatment. An efficient real-time reporting and management of AE can be developed and tested for effective DR-TB control.


2019 ◽  
Author(s):  
Arjunkumar Hardas Jakasania ◽  
Kalpita Shringarpure ◽  
Dixit Kapadia ◽  
Radhika Sharma ◽  
Kedar Mehta ◽  
...  

Abstract Background: Unsuccessful treatment outcomes among patients with drug resistant tuberculosis (DR-TB) are due to high rates of adverse events (AEs). However, information related to AEs is not systematically collected and managed under programmatic setting. The present study assessed the a) incidence and pattern of adverse events in first three months of DR-TB treatment initiation; b) treatment seeking behaviour for AE management; and c) explore the challenges in seeking treatment and reporting AEs. Methods: This mixed methods study included all patients diagnosed and initiated on treatment under RNTCP during July-September 2018 at Ahmedabad DR-TB centre. The patients were interviewed telephonically and assessed for all AEs experienced by them. In-depth interviews and key-informant interviews were conducted among patients, DOTS supervisors and programme staffs (treatment supervisors, medical officer and district program manager). Results: A total 207 AEs were reported by the 74 DR-TB patients. All patients experienced at least one AE during initial treatment period. Incidence rate of AEs (experienced) was 3.11 (1st month-4.6, 2nd month-2.7, 3rd month-2.02) per 100 person days. Of the 207 AEs, gastro-intestinal (59, 28.3%), ophthalmic (32, 15.4%) and otolaryngology (25, 11.9%) system related AEs were commonly experienced. Treatment was not sought in two-fifths of the AEs. Themes and subthemes related to challenges in treatment seeking or reporting of AEs were 1) Patient related-Misconceptions, accessibility and affordability of management, lack of counselling support, stigma and discrimination, and past treatment experience; 2) Health system related- lack of guideline and training for AE management, and poor coordination between hospital and tuberculosis centre. Conclusion: The incidence of AEs was high among patients with DR-TB in the first three months of treatment and treatment seeking/reporting was low. Adequate health education and counselling of the patient and orientation of the health systems are the need of the hour. An efficient real-time reporting and management of AE can be developed and tested for effective DR-TB control. Keywords: Adverse event, Drug resistant tuberculosis, Operational research, Incidence, India, Treatment seeking.


PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0255357
Author(s):  
Nguyen Bao Ngoc ◽  
Hoa Vu Dinh ◽  
Nguyen Thi Thuy ◽  
Duong Van Quang ◽  
Cao Thi Thu Huyen ◽  
...  

Objective Management of multidrug-resistant tuberculosis (MDR-TB) is a significant challenge to the global healthcare system due to the complexity and long duration of the MDR-TB treatment. This study analyzed the safety of patients on longer injectable-based MDR-TB treatment regimens using active pharmacovigilance data. Method We conducted an observational, prospective study based on active pharmacovigilance within the national TB program. A total of 659 MDR-TB patients were enrolled and followed up at 9 TB- hospitals in 9 provinces of all 3 regions in Vietnam between 2014 and 2016. Patients received a treatment regimen (standardized or individualized) based on their drug susceptibility test result and their treatment history. Baseline and follow-up information was collected at the start and during treatment. Adverse events (AE) were defined and classified as serious adverse events (SAEs) or otherwise. Multivariate Cox regression following the Iterative Bayesian Model Averaging algorithm was performed to identify factors associated with AE occurrence. Results Out of 659 patients assessed, 71.3% experienced at least one AE, and 17.5% suffered at least one SAE. The most common AEs were gastrointestinal disorders (38.5%), arthralgia (34.7%), and psychiatric disorders (30.0%). The proportion of patients with nephrotoxicity and hearing loss or vestibular disorders were 7.4% and 15.2%, respectively. 13.1% of patients required modifications or interruption of one or more drugs. In 77.7% of patients, treatment was completed successfully, while 9.3% lost to follow-up, in 3.0% treatment failed, and 7.4% died. Some significant risk factors for nephrotoxicity included diabetes mellitus (HR = 8.46 [1.91–37.42]), renal dysfunction (HR = 8.46 [1.91–37.42]), alcoholism (HR = 13.28 [5.04–34.99]), and a higher average daily dose of injectable drugs (HR = 1.28 [1.14–1.43]). Conclusion While a majority of patients on the longer injectable-based regimens experienced non-serious AEs during MDR-TB treatment, one in six patients experienced at least an SAE. Active TB drug-safety monitoring is useful to understand the safety of MDR-TB treatment and explore the risk factors for toxicity. All-oral, shorter MDR-TB regimens might be able to reduce the inconvenience, discomfort, and toxicity of such regimens and increase adherence and likelihood of successful completion.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Brenda Nakafeero Simbwa ◽  
Achilles Katamba ◽  
Elizabeth B. Katana ◽  
Eva A. O. Laker ◽  
Sandra Nabatanzi ◽  
...  

Abstract Background Emergence of drug resistant tuberculosis (DR-TB) has aggravated the tuberculosis (TB) public health burden worldwide and especially in low income settings. We present findings from a predominantly nomadic population in Karamoja, Uganda with a high-TB burden (3500 new cases annually) and sought to determine the prevalence, patterns, factors associated with DR-TB. Methods We used mixed methods of data collection. We enrolled 6890 participants who were treated for tuberculosis in a programmatic setting between January 2015 and April 2018. A cross sectional study and a matched case control study with conditional logistic regression and robust standard errors respectively were used to the determine prevalence and factors associated with DR-TB. The qualitative methods included focus group discussions, in-depth interviews and key informant interviews. Results The overall prevalence of DR-TB was 41/6890 (0.6%) with 4/64,197 (0.1%) among the new and 37/2693 (1.4%) among the previously treated TB patients respectively. The drug resistance patterns observed in the region were mainly rifampicin mono resistant (68.3%) and Multi Drug-Resistant Tuberculosis (31.7%). Factors independently associated with DR-TB were previous TB treatment, adjusted odds ratio (aOR) 13.070 (95%CI 1.552–110.135) and drug stock-outs aOR 0.027 (95%CI 0.002–0.364). The nomadic lifestyle, substance use, congested homesteads and poor health worker attitudes were a great challenge to effective treatment of TB. Conclusion Despite having the highest national TB incidence, Karamoja still has a low DR-TB prevalence. Previous TB treatment and drug stock outs were associated with DR-TB. Regular supply of anti TB medications and health education may help to stem the burden of TB disease in this nomadic population.


2019 ◽  
Vol 11 (6) ◽  
pp. 520-527 ◽  
Author(s):  
Edson Mollel ◽  
Isack Lekule ◽  
Lutgarde Lynen ◽  
Tom Decroo

Abstract Background During 2009–2013, Xpert MTB/RIF testing was decentralized in Tanzania. Standardized treatment of multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB) was centralized at the Kibong’oto Infectious Diseases Hospital. Initially, Xpert MTB/RIF results were confirmed and complemented with phenotypic drug susceptibility testing before MDR-TB treatment was started. Since 2013, the decision to start MDR-TB treatment in patients with RR-TB relied on Xpert MTB/RIF results. Methods A retrospective cohort study of predictors of unsuccessful treatment outcomes (including death, lost to follow-up and treatment failure) was carried out. Results During the study period, 201 patients started MDR-TB treatment. The number of patients starting MDR-TB treatment increased over time. Out of 201 patients, 48 (23.9%) had an unsuccessful treatment outcome. The median time between sample collection and MDR-TB treatment initiation was reduced from 155 d (IQR 40–228) in the 2009–2012 period to 26 d (IQR 13–64) in 2013. Patients who started MDR-TB treatment in 2013 were more likely (adjusted OR 2.3; 95% CI 1.1–4.7; p=0.02) to have an unsuccessful treatment outcome. Conclusions Xpert MTB/RIF testing increased enrolment on MDR-TB treatment. Reliance on Xpert MTB/RIF results to start MDR-TB treatment reduced time to treatment. However, treatment outcomes did not improve.


2021 ◽  
Author(s):  
Brenda Nakafeero Simbwa ◽  
Elizabeth B. Katana ◽  
Sandra Nabatanzi ◽  
Emmanuel Sendaula ◽  
Charles A. Karamagi ◽  
...  

Abstract Background: Emergence of Drug Resistant Tuberculosis (DR-TB) has aggravated the Tuberculosis (TB) public health burden worldwide and especially in low income settings. We present findings from a predominantly nomadic population in Karamoja, Uganda with a high-TB burden (3,500 new cases annually) and sought to determine the prevalence, patterns, factors associated with DR-TB. Methods: We used mixed methods of data collection. We enrolled 6890 participants who were treated for tuberculosis in a programmatic setting between January 2015 and April 2018. A cross sectional study and a matched case control study with conditional logistic regression and robust standard errors respectively were used to the determine prevalence and factors associated with DR-TB. The qualitative methods included focus group discussions, in-depth interviews and key informant interviews. Results: The overall prevalence of DR-TB was 41/6890 (0.6%) with 4/64197 (0.1%) among the new and 37/2693 (1.4%) among the previously treated TB patients respectively. The drug resistance patterns observed in the region were mainly rifampicin mono resistant (68.3%) and Multi Drug-Resistant Tuberculosis (31.7%). Factors independently associated with DR-TB were previous TB treatment, adjusted odds ratio (aOR) 13.070 (95%CI: 1.552 – 110.135) and drug stock-outs aOR 0.027 (95%CI: 0.002-0.364). The nomadic lifestyle, substance use, congested homesteads and poor health worker attitudes were a great challenge to effective treatment of TB. Conclusion: Despite having the highest national TB incidence, Karamoja still has a low DR-TB prevalence. Previous TB treatment and drug stock outs were associated with DR-TB. Regular supply of anti TB medications and health education may help to stem the burden of TB disease in this nomadic population.


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