Description of the development and preliminary validation of antiretroviral therapy adverse event detection trigger tool for adult human immunodeficiency virus/acquired immunodeficiency syndrome patients

Abstract

Abstract Background: The Institute for Healthcare Improvement (IHI) Global Trigger Tool detects generic patient harm yet is not tailored to antiretroviral therapy (ART)-associated adverse drug events (ADEs) in adults living with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome – a critical pharmacovigilance gap in care. Aim: The study is aimed at developing and preliminarily validating an HIV-specific trigger tool for ADE surveillance. Materials and Methods: Candidate triggers were compiled from literature, expert consultation, and patient interviews, then refined through a four-round modified Delphi survey of clinicians and pharmacovigilance specialists. Inter-rater reliability (κ) and content validity indices (CVIs) were calculated. The finalized tool was pilot-tested by retrospective review of 60 randomly selected ART patient records. Results: Consensus produced 52 triggers, organized into two domains (specific and nonspecific) and 13 specific subcategories. The expert agreement was substantial (κ =0.67). The scale-level CVI averaged 0.95. Pilot application detected 96 trigger occurrences, yielding 60 confirmed ADEs (positive predictive value = 62.5%). Switch or substitution of ART (22%) was the most common trigger, while acute kidney injury accounted for 17% of ADEs. Conclusion: The newly developed trigger tool demonstrates strong content validity and practical utility for identifying ART-related ADEs in adult HIV populations. Comparative studies against conventional detection methods are required to establish sensitivity and broader applicability across diverse healthcare settings.