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

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.

Frequency, management and impact of adverse events on treatment outcomes in patients with multidrug resistant tuberculosis in Balochistan, Pakistan

“…Our findings revealed that almost all (99.6%) patients encountered at least one AE, with an average of four different events per patient. The frequency of AEs observed in our study was comparable with the rate reported by a study conducted in India (100%) (Jakasania et al, 2020 ), but was higher than the rates reported by studies conducted at other PMDT units in Pakistan (range: 63.7–72.3%) (Ahmad, Ahuja, et al, 2018 ; Atif et al, 2022 ), China (90.7%) (Zhang et al, 2017 ), KwaZul-Natal (80.6%) (Brust et al, 2013 ), Namibia (89%) (Sagwa et al, 2014 ), Latvia (79%) (Bloss et al, 2010 ) and Viet Nam (71.3%) (Ngoc et al, 2021 ). Variability in the frequency of AEs among published studies can be attributed to several factors.…”

Efek Samping Pengobatan Pada Pasien Tuberkulosis

“…Tingkat kejadian efek samping adalah bulan pertama yang paling tinggi dibanding bulan kedua. Keluhan yang di alami yaitu diantaranya terkait sistem gastrointestinal (59, 28,3%), oftalmik (32, 15,4%) dan THT (25, 11,9%) paling sering dialami (Jakasania et al, 2020). Studi observasional cross-sectional menunjukan Sebanyak 168 pasien (132 laki-laki, 36 perempuan) menunjukan efek samping obat yang terutama melibatkan sistem pencernaan (39%), sistem perkemihan (32%), sistem musculo-skeletal (13%), sistem saraf pusat (7%), dermatologis (6%) (Singh & Pant, 2014).…”

Stressors and Resilience within the Cassava Value Chain in Nigeria: Preferred Cassava Variety Traits and Response Strategies of Men and Women to Inform Breeding

“…This study adopted the use of Computer Assisted Personal Interviewing (CAPI) due to its relative advantages in integrating data collection, data entries, editing, coding, and cleaning into a single process over the traditional paper-and-pencil techniques [63], among other benefits [64,65]. The survey was based on a structured questionnaire imputed to digital software Kobocollect [66,67] and collected using tablets or mobile phones. Our key variables, which included cassava traits, the consequences of stressors, and response strategies, were measured with a representative list of items obtained from the literature, the expert review/validation workshop, the pretest of research instruments, and qualitative sessions (see Table S2).…”