Development and validation of the questionnaire to assess the knowledge, attitude, and practice of pharmacovigilance among registered Ayurvedic practitioners in India
Achintya Mitra, Bhagwan Sahai Sharma, Mukesh B. Chincholikar, Shruti Khanduri, Thugutla Maheswar, Animesh Sen, Arunabh Tripathi, Rabinarayan AcharyaAbstract
BACKGROUND:
Drug safety is a critical concern given the rising global demand for Ayurvedic medicines. The World Health Organization has urged member states to prioritize pharmacovigilance, particularly for drugs of natural origin. In India, a national pharmacovigilance program for traditional medicine under the Ministry of Ayush has been operational since 2018. This study aimed to develop and validate a reliable questionnaire to assess knowledge, attitude, and practices (KAPs) related to pharmacovigilance among registered Ayurvedic practitioners (RAPs).
MATERIALS AND METHODS:
This study was conducted between July and September 2024 across ten Indian states, utilizing a questionnaire administered to RAPs. Face validity was assessed qualitatively, and content validity was evaluated using the Content Validity Index (CVI) at both item (I-CVI) and scale levels (S-CVI/Ave and S-CVI/UA). Reliability was assessed using Cronbach’s alpha.
RESULTS:
A total of 89 RAPs participated in the study. The questionnaire was refined from 59 to 35 items across the KAP domains following expert evaluation and pilot testing. Content validity improved after item refinement, with S-CVI/Ave increasing from 0.82 to 0.99 and S-CVI/UA increasing from 0.56 to 0.94, indicating strong expert agreement. The instrument demonstrated acceptable internal consistency, with a Cronbach’s alpha of 0.75 and standardized alpha of 0.77. Item-wise response distributions obtained during pilot administration supported the clarity and applicability of the questionnaire among the participants.
CONCLUSION:
The developed questionnaire is reliable, valid, and suitable for assessing pharmacovigilance knowledge and practices among Ayurvedic practitioners in India, with potential utility in training and policy evaluation.