Enhancing the Safety of Medical Devices: Development of a Knowledge Attitudes and Practices (KAP) Assessment Tool and to Assess the Impact of Materiovigilance Sensitization Programs Among Dental Professionals
Author(s)
JEESA GEORGE1, Adusumilli Pramod Kumar, PhD2, Vibha Shetty, MDS, PhD3, Vivekanandan Kalaiselvan, PhD4.
1Assistant Professor, M S Ramaiah University Of Applied Sciences, Bangalore, India, 2M S Ramaiah University Of Applied Sciences, Bangalore, India, 3M S Ramaiah University Of Applied Sciences, Bengaluru, India, 4Indian Pharmacopoeia Commission, Ghaziabad, India.
1Assistant Professor, M S Ramaiah University Of Applied Sciences, Bangalore, India, 2M S Ramaiah University Of Applied Sciences, Bangalore, India, 3M S Ramaiah University Of Applied Sciences, Bengaluru, India, 4Indian Pharmacopoeia Commission, Ghaziabad, India.
OBJECTIVES: Materiovigilance is crucial for patient safety by monitoring the adverse events associated with medical devices. This involves the detection, assessment, understanding, and prevention of adverse events related to medical devices. This study aimed to develop and validate a reliable knowledge, attitude, and practice (KAP) questionnaire on materiovigilance and to evaluate the effectiveness of a sensitization program in enhancing dental professionals' KAP regarding the identification and reporting of adverse events related to medical devices.
METHODS: A 45-item questionnaire was developed with 15 items each for knowledge, attitude, and practice. Content validity was evaluated by 15 experts using the Content Validity Ratio (CVR) with a threshold of >0.49 and Item- & scale-level content validity indices (CVI). The face validity was assessed. Reliability was tested using Cronbach's alpha. A cross-sectional pre-test survey was conducted, followed by a materiovigilance awareness program and a post-test after 21 days to assess its effectiveness.
RESULTS: The final questionnaire included 24 items with a Scale-CVI of 0.95, indicating excellent content validity. The Cronbach's alpha was 0.91, confirming strong reliability. The study showed significant improvement in KAP scores after conducting the awareness program. Initially, 25% of the participants knew about the Materiovigilance Programme of India (MvPI), increasing to 98% post-intervention. Positive attitudes towards adverse event reporting increased to 96%, although only 6% had prior training. The Wilcoxon Signed-Rank Test showed significant improvements in knowledge, attitude, and practice scores post-intervention (p < 0.001). The researcher received training in materiovigilance from the Indian Pharmacopoeia Commission, Government of India.
CONCLUSIONS: This study validated a KAP questionnaire to assess materiovigilance awareness among dentists. The program significantly enhanced knowledge, attitude, and practice, highlighting the importance of education to mitigate risks associated with dental devices.
METHODS: A 45-item questionnaire was developed with 15 items each for knowledge, attitude, and practice. Content validity was evaluated by 15 experts using the Content Validity Ratio (CVR) with a threshold of >0.49 and Item- & scale-level content validity indices (CVI). The face validity was assessed. Reliability was tested using Cronbach's alpha. A cross-sectional pre-test survey was conducted, followed by a materiovigilance awareness program and a post-test after 21 days to assess its effectiveness.
RESULTS: The final questionnaire included 24 items with a Scale-CVI of 0.95, indicating excellent content validity. The Cronbach's alpha was 0.91, confirming strong reliability. The study showed significant improvement in KAP scores after conducting the awareness program. Initially, 25% of the participants knew about the Materiovigilance Programme of India (MvPI), increasing to 98% post-intervention. Positive attitudes towards adverse event reporting increased to 96%, although only 6% had prior training. The Wilcoxon Signed-Rank Test showed significant improvements in knowledge, attitude, and practice scores post-intervention (p < 0.001). The researcher received training in materiovigilance from the Indian Pharmacopoeia Commission, Government of India.
CONCLUSIONS: This study validated a KAP questionnaire to assess materiovigilance awareness among dentists. The program significantly enhanced knowledge, attitude, and practice, highlighting the importance of education to mitigate risks associated with dental devices.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EPH72
Topic
Epidemiology & Public Health, Organizational Practices, Study Approaches
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
No Additional Disease & Conditions/Specialized Treatment Areas