Development and validation of patient information leaflet for coronary heart disease patients
BC Vinay1, CS Shastry1, Subramanyam Kodangala2, Uday Venkat Mateti1, Krishna Bhat3
1 Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India
2 Department of Cardiology, K.S. Hegde Medical Academy, Justice K.S. Hegde Charitable Hospital, Nitte (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India
3 Department of Statistics, K.S. Hegde Medical Academy, Nitte (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences Paneer, Nitte (Deemed to be University), Deralakatte, Mangaluru - 575 018, Karnataka
Source of Support: None, Conflict of Interest: None
Background: Patient information leaflets (PILs) are effectively used to improve the patient's knowledge about medications, disease, diet, and lifestyle modifications.
Aim: This study aims to develop and evaluate PILs for coronary heart disease patients.
Materials and Methods: Primary, secondary, and tertiary resources were used to develop PILs. The developed PILs were validated by four doctors, four academic pharmacists, and one dietician. PILs design and layout was prepared using barker able leaflet design (BALD) criteria. PILs readability was assessed using the Flesch Reading Ease test (FRE), Flesch–Kincaid Grade Level (FKGL), and user readability methods. User opinion on PILs content and design was obtained from patients.
Results: The FRE and FKGL readability scores were 61.5 and 7.4, respectively. The BALD criteria scores for English, Kannada, and Malayalam PILs were 28, 27, and 26, respectively. The overall user testing readability means scores had significantly improved from 45 to 79.30. Nearly 82.55% of patients rated the PILs as good design and content.
Conclusion: The developed leaflet met the standard criteria for easy reading and comprehension. The majority of the patients gave good opinion on the content and design of the PILs.