“Side effects-part of the package” – A mixed methods approach to adverse events among patients with DR-TB under RNTCP Gujarat, India

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.