Development, validation, user testing of patient information leaflet to improve awareness of metabolic side effects in patients on atypical antipsychotics

Background: Metabolic adverse effects of second-generation antipsychotics (SGAs) have been well-documented in literature. This study aimed to develop, validate, and evaluate the usefulness of patient information leaflet (PIL) by user testing method to improve metabolic monitoring for psychiatric patients prescribed with SGAs. Methods: The study included out-patients above 18 years of age diagnosed with schizophrenia, schizoaffective, bipolar disorders prescribed with SGAs. Database such as micromedex, guidelines on developing PIL and factsheets on antipsychotics were used to prepare the content of the leaflet and was given to experts for validation. The PIL covered information on definition of antipsychotic and its types, metabolic syndrome and its prevention such as lifestyle modifications and regular monitoring. Readability of the PIL was assessed using Flesch reading ease (FRE), Flesch Kincaid grade level (FK-GL) and user testing in 20 similar patient population. Results: The BALD scores on layout and design of the PILs was found to be 29. The FRE readability test score was found to be 63.5 and FKGL test score was found to be 7.6. Among the 20 patients, 5 of them favoured English PILs, while 15 chose Kannada PILs. The overall pre and post user-testing mean scores for knowledge assessment significantly increased from 60.62 ± 23.39 to 91.25 ± 11.54. Overall, about 85 % of patients gave the PIL leaflets a good rating. Conclusion: Patient education materials of high quality that are created with pictures may aid in a better knowledge of the treatment for psychiatric patients who are on long term SGA therapy.