Preparation and Validation of User-based Patients Information Leaflets (PILs) for COPD Patients in Indian Regional Languages: A Prospective Observational Study

Objectives: Extensive literature survey revealed that chronic obstructive pulmonary disease (COPD) is one of the primary burdens for low-income countries like India. Out of around 30 million COPD patients in India, a considerable number of patients are uneducated about the basics of their disease prevention and medication. Patient information leaflets (PILs) are well accepted materials to educate patients/users about medications, disease and lifestyle modifications. Thus PILs printed in regional languages will certainly act as a valuable tool to disseminate and retain patient’s information. Methods: PILs are developed in the English language by referring to various model leaflets that are available from different sources such as “Patient UK”, MICROMEDEX Database, GOLD guidelines. The content of the leaflet was validated by physicians. Cloze test was identified as a possible test for assessing the readability of leaflets in English, Kannada, Malayalam and in Hindi. A user-based Cloze test was performed on twenty COPD patients of in each language. Results: The FRE score achieved after the 5th stage of modification was 77.3, and the FK-GL score achieved was 4.7, which is considered to be good readability of leaflets. User testing scores show significant improvement of knowledge after reading PILs. Conclusion: Present study strongly suggest that the development of patient information leaflet in regional language is likely to have a standard readability score and useful layout design. The prepared leaflet is easily readable and comes out to be user friendly for COPD patients.