Development and Evaluation of Patient Information Leaflet for Diabetic Foot Ulcer Patients

Background Patient education (PE) is as important as medical and surgical interventions in the management of diabetic foot ulcer (DFU). Patient information leaflets (PILs) are globally accepted patient counseling aids. Objectives This study aimed at developing PILs for DFU patients and investigating its validation. Methods The PILs were prepared based on different model leaflets available from various online resources, including "Patient UK". The PILs readability was evaluated by Flesch/ Flesch-Kincaid readability (FRE/FK-GL) method before user-testing (n = 34 DFU patients) by quasi-experimental methods in patients with DFU. Additionally, user-opinion on legibility and content of the PIL was also determined. Baker Able Leaflet Design (BALD) method was employed to assess the layout and design characteristics of the PIL. Results The best FRE score achieved was 73.9 and the FK-GL score was 6.1. The mean BALD assessment score for English and Kannada versions of PIL were 27 and 26, respectively. The ICC of the test-retest reliability of user-testing and user-opinion questionnaires in both English and Kannada ranged from 0.91 to 0.96. The overall user-testing knowledge-based mean score significantly improved from 43.4 to 69.7 (P < 0.05). Overall, 82.4% of patients reported overall user-opinion on legibility and content of the PIL as good. Conclusions The developed PILs met the criteria of fairly easy readability and good layout design. The user-opinion of the majority of patients reported the PIL content, legibility, and design as good. The Pictogram-based PILs (P-PILs) was found to be an effective PE tool in DFU patients.