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

Abstract

Background: A Patient Information Leaflet (PIL) is a widely accepted counselling aid to educate patients. The current study aimed to prepare and validate an easy-to-understand PIL explicitly tailored for patients with Heart Failure with reduced Ejection Fraction (HFrEF). Its psychometric properties were evaluated to confirm its reliability and readability.Materials and Methods: Information was curated from credible sources and validated by experts using the Lawshe method. Readability and design were assessed with metrics like the Flesch Reading Ease (FRE) Score, Flesch-Kincaid Grade Level (FKGL), and the Baker-Able Leaflet Design (BALD) index. A user testing questionnaire was also developed and validated for reliability through test-retest methods. This same questionnaire evaluated the PIL's readability before and after exposure to the PIL, ensuring it effectively communicated crucial information to the target population.Results: The English PIL scored 76.9 on FRE and four on FKGL, showing good readability. BALD scores were 29 (English) and 25 (Kannada and Malayalam), denoting excellent design quality across languages. A psychometric evaluation of 60 HFrEF patients (English [n=15], Malayalam [n=15], Kannada [n=30]) using a reliable UTQ (ICC=0.94) significantly improved the score from 36.81±10.6 to 88.29±10.11 (p<0.001), highlighting the ease of understanding. Moreover, 92% of patients provided favourable opinions about the PIL, describing it as well-designed and well-written.Conclusion: This study underscores the significance of a well-developed and validated PIL as a potent educational resource, aiding health professionals in designing and assessing PIL using robust scientific methodologies.

Keywords: Heart failure; Patient information leaflet; Validation; Patient education; Psychometrics