Development and Validation of an ADR Awareness and Reporting Questionnaire for Pharmacovigilance in India

Abstract

Introduction: Under-reporting of adverse drug reactions (ADRs) remains a major challenge in pharmacovigilance, particularly in low- and middle-income countries like India. Accurate assessment of knowledge, awareness, and reporting practices among healthcare students and professionals requires valid and reliable measurement tools. Methods: A 25-item questionnaire was constructed based on pharmacovigilance guidelines, literature review, and expert input. Validation followed a multi-step process: • Face validity: evaluated by 9 educational experts using a 4-point clarity scale; Item-level and Scale-level Face Validity Indices (FVI) were calculated. • Content validity: assessed by the same expert panel using Lawshe’s Content Validity Ratio (CVR) and overall Content Validity Index (CVI). • Construct validity: examined through Kaiser-Meyer-Olkin (KMO) measure and Bartlett’s test of sphericity. • Reliability: determined via Cronbach’s alpha in a pilot sample (n=10). • Pilot testing: conducted with 10 representative participants to assess feasibility, completion time, and acceptability. Results: Face validity was excellent (average FVI = 0.9511; all items ≥ 0.78). Content validity was strong (21 items CVR = 1.00, 3 items CVR = 0.78; overall CVI = 0.9736), supporting retention of all 25 items. Sampling adequacy for factor analysis was meritorious (KMO = 0.812) with highly significant sphericity (Bartlett’s χ² = 2845.67, p < 0.001). Internal consistency was moderate (Cronbach’s α = 0.6849), acceptable for exploratory research. Pilot testing confirmed feasibility (completion time 10–15 minutes) with high participant-reported clarity and relevance; no major revisions were required. Discussion: The developed 25-item questionnaire demonstrates excellent face and content validity, strong preliminary construct validity indicators, and acceptable reliability for early-stage pharmacovigilance research. It is a feasible, clear, and theoretically sound instrument suitable for assessing ADR awareness and reporting practices among healthcare students and professionals in India and similar settings. Further validation in larger samples and confirmatory factor analysis is recommended to strengthen psychometric properties.