Sekhar M Sonal, Mk Unnikrishnan, Vyas Navya, Rodrigues Gabriel Sunil
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, India.
Department of Public Health, Manipal University, Manipal, India.
Int J Endocrinol Metab. 2017 Jun 21;15(3):e55454. doi: 10.5812/ijem.55454. eCollection 2017 Jul.
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.
This study aimed at developing PILs for DFU patients and investigating its validation.
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.
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.
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.
在糖尿病足溃疡（DFU）的管理中，患者教育（PE）与药物和手术干预同样重要。患者信息手册（PILs）是全球公认的患者咨询辅助工具。
本研究旨在为DFU患者开发PILs并对其进行验证。
基于从包括“英国患者”在内的各种在线资源中获取的不同模板手册来编写PILs。在对DFU患者进行准实验性用户测试（n = 34名DFU患者）之前，通过弗莱施/弗莱施-金凯德可读性（FRE/FK-GL）方法评估PILs的可读性。此外，还确定了用户对PILs的易读性和内容的意见。采用贝克-艾布尔手册设计（BALD）方法评估PILs的布局和设计特征。
获得的最佳FRE分数为73.9，FK-GL分数为6.1。PILs英文和卡纳达语版本的平均BALD评估分数分别为27和26。英文和卡纳达语的用户测试和用户意见问卷的重测信度的组内相关系数（ICC）范围为0.91至0.96。基于知识的总体用户测试平均分从43.4显著提高到69.7（P < 0.05）。总体而言，82.4%的患者对PILs的易读性和内容的总体用户意见为良好。
所开发的PILs符合可读性相当容易和布局设计良好的标准。大多数患者的用户意见表明PILs的内容、易读性和设计良好。基于象形图的PILs（P-PILs）被发现是DFU患者有效的PE工具。
