Development and validation of patient information leaflet for coronary heart disease patients

Abstract

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.

Development, Validation, and Psychometric Analysis of a Patient Information Leaflet for Heart Failure with Reduced Ejection Fraction

“…A similar mean age, male-female ratio, and educational background to Vinay et al were observed among HFrEF patients in this study in which the majority of patients (72.27%) were males with a mean age of 58.06± 8.35 and had either completed high school or primary school education. 30 Based on the ICC, the most commonly used statistical method to assess test-retest reliability, the developed UTQ is reliable in all three languages. Based on the results of an assimilation study conducted to evaluate a PIL for haemodialysis patients, good reliability scores of 0.93 and 0.98 were obtained for Kannada and English UTQ, respectively.…”

“…A score ranging from 60 to 70 is generally acceptable. The readability of a document can be assessed using the following scale: very easy (90-100), easy (80-89), fairly easy (70-79), standard (60-69), fairly difficult (50-59), difficult (30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42)(43)(44)(45)(46)(47)(48)(49), and very confusing (0-29). 17 The PIL has been modified to improve its FRE/FKGL scores.…”

A cross-sectional audit of informed consent of online survey: Characteristics and adherence to prevalent guidelines

“…[ 10 ] The method was previously used by studies concerned with assessing the ease of reading in India. [ 11 12 ]…”

Informed consent in dermatology: a narrative review

“…18 The level of reading difficulty of the informed consent paper can be assessed using several measurements, including the Flesch Kincaid Grade Level which is a widely used readability formula and results in a reading grade equivalent to US grade level of education. 19,20 The Gunning Fog Index is also widely used and estimates the number of years of formal education that a reader needs to be able to understand the text, which can be helpful for assessing informed consent forms in other countries. There are many online tools available for calculating both scores, and the aim for informed consent and patient education materials should be for a reading level of US grade 6.…”