Development and Validation of Patient Information Leaflet for Schizophrenia

Abstract

People with severe mental illnesses like schizophrenia demonstrate a high rate of therapeutic noncompliance in contrast to other forms of mental illnesses. Educating patients regarding the disease and treatment helps to overcome the barriers of their resistance toward the prescribed regimen. Numerous tools have been developed for educating patients and the most convenient and cost-effective form of educational tool is a leaflet. The study aims to develop and validate a patient information leaflet (PIL) for patients with schizophrenia. The PIL contents were generated from various sources of literature and discussion with several experts in the fields of psychiatry, dietetics, and pharmacy, followed by validation using the content validation index (CVI) method. The Flesch reading ease (FRE) and Flesch–Kincaid Grade Level (FKGL) formulas were employed to assess readability and evaluate layout and design, Baker-Able Leaflet Design (BALD) criteria were utilized. The prepared draft PIL obtained CVI scores of 0.94 (relevance) and 0.84 (clarity), indicating good content validity. The readability scores 74.4 (FRE) and 4 (FKGL) denoted that the textual contents in the PIL are relatively easy to read by any person with an educational grade of four and above. The BALD scores of 29 (English) and 26 (Malayalam and Kannada) represent the PIL good layout and design. A draft PIL for patients with schizophrenia is prepared and validated. Further user-testing analysis is needed to evaluate the PIL’s efficiency in the target population.