Development and Validation of Questionnaire to Assess The Knowledge, Attitude and Practice towards Adverse Drug Reactions Reporting among Healthcare Professionals

Abstract

Adverse drug reactions (ADR) are an important public health problem in terms of mortality, morbidity, socio-economic consequences and also its management. The aim of the study was to develop a validated questionnaire on knowledge, attitude and practice pattern (KAP) of healthcare professionals towards ADR reporting as per Central Drugs Standard Control Organization suspected adverse drug reaction reporting form. The development of the questionnaire was conducted in a standardized manner, using an accepted measure development methodology which included item development, content and face validation, pilot testing, and test-retest validation with appropriate statistical tests using SPSS software. The statistical analysis used were Descriptive statistics, Cronbach’s α, Cohen’s Kappa, T test, paired T test. A final set of 25 questions were framed of which 14, 7 and 4 are to assess KAP respectively. The knowledge questions evaluated knowledge on burden of ADR, reporting ADRs and pharmacovigilance. The attitude questions included opinions about reporting an ADR and includes the agreement towards preformed scale consisting agree, disagree and don’t know. The practice questions collect the information regarding the approach to ADR or adverse event in their clinical experience. For categorization of knowledge, composite score was derived and divided into three groups. Score more than 66% is considered as adequate knowledge, 34 to 66% and less than 34% is considered as moderate and poor knowledge respectively. Availability of validated questionnaire which can give a consistent result is a hallmark of this study and this is a step towards providing reproducible results which can be used to assess KAP and to plan for necessary interventions.