Development and Validation of the Patient Information Leaflet for Pregnant Women

Abstract

Objective: The objective of the study is to prepare, validate and analyze the user understanding of the pictogram-based leaflet. Methods: The patient information leaflet (PIL) was prepared by referring to national and international guidelines. It was reviewed by an expert committee for content and layout. The readability of the PIL was assessed using the Flesch readability ease (FRE) score and Flesch Kincaid Grade Level score (FK-GL), while the layout was validated using Baker Able leaflet design (BALD) criteria. In addition, a pre and post-test study of user-testing and user-opinion methods were employed to validate both English and Kannada versions of PIL. Results: The FRE, FKGL, and BALD score of the final version of the prepared leaflet was found to be 70.5, 5.8, and 31, respectively. The user testing scores of PIL were improved from pre-test score of 62.5 ± 9.26 to post-test score of 88.5 ± 6.99 with P < 0.0001. The overall patient education materials assessment tool for printable materials score assigned by study participants was found to be good 32 (80.32%) and average 8 (20%). Conclusion: This study showed that the use of well-developed and validated leaflet as an effective educational tool for patient education may have a positive impact on knowledge and attitude of pregnant women toward the antenatal care for better pregnancy outcomes.