Development, Validation and Readability Assessment of Patient Information Leaflet on Breast Cancer

The primary objective of the study is to develop, validate, translate and to assess the user readability of PIL for patients diagnosed with breast cancer. The leaflet on breast cancer was prepared by referring various primary, secondary and tertiary resources of information. The prepared PIL was validated by the expert committee of eight members including academic and clinical pharmacists, general physician and medical oncologist. User readability testing was conducted. The opinion of the subjects on the content, layout and design of the PIL was also attained. A total of 50 patients were enrolled for user readability testing. The overall user readability score was significantly increased from 39.20 ± 17.12 to 73.20 ± 13.76. A good opinion on the content, layout and design of the PIL was reported by ninety two percent of the study patients. The study concluded the significant impact of validated PIL on the level of knowledge of study subjects. The study was prospectively registered in Clinical Trial Registry of India (Ref No: CTRI/2020/07/026688).