eng Oriental Scientific Publishing Company Biomedical and Pharmacology Journal 0974-6242 2025-12-30 18 4 3225 3233 10.13005/bpj/3330 69511 article Ahmad Kamal Ariffin Abdul Jamil 1 Nur Hasyimah Jamrah Musa 1 Umar Idris Ibrahim 1 Nurul Afiedia Roslim 2 Ng Yen Ping 3 Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, Universiti Sultan Zainal Abidin, Besut, Malaysia Department of Marine Science, Terengganu State Fisheries Department, Besut, Malaysia Faculty of Pharmacy, Quest International University, 227, Jalan Raja Permaisuri Bainun, Ipoh, Perak, Malaysia When combined with renin-angiotensin-aldosterone system (RAAS) blockers, pentoxifylline (PTX) has been demonstrated to decrease proteinuria and slow the decline of kidney function in patients with diabetic kidney disease (DKD). However, patients find it difficult to understand complex medical information in traditional drug information leaflets. In order to improve medication comprehension among DKD clinical trial participants, a pictogram-based drug information leaflet (P-DIL) was created for PTX. The study's objective was to develop and validate a P-DIL for PTX as an adjuvant treatment for patients enrolled in DKD clinical trials. This study comprised two phases: (I) development and (II) validation. In Phase I, leaflet content was adapted from Consumer Medicine Information (CMI) and refined through healthcare professionals experts’ feedback. Items were rated for appropriateness, and those scoring ≥50% were included. In Phase II, the PTX P-DIL was validated using a structured questionnaire based on the Educational Content Validation Instrument in Health (ECVIH). Content validity indices—Item-level (I-CVI), Scale-level Universal Agreement (S-CVI/UA), and Scale-level Average (S-CVI/Ave)—were calculated. Readability was assessed using the Flesch Reading Ease (FRE) and Flesch–Kincaid Grade Level (FKGL) formulae. Eleven out of twelve proposed contents were included in the final leaflet. The I-CVI values ranged from 0.7 to 1.0, S-CVI/Ave was 0.94, and S-CVI/UA was 0.67, indicating moderate to high content validity. Readability assessment yielded low FRE and FKGL scores, suggesting that it was difficult to read and suitable for college-level students. Experts deemed the PTX P-DIL suitable for patients in DKD clinical trials, and it showed moderate to high validity. The use of pictograms is anticipated to improve comprehension among patients with different reading levels, despite the text's high level of complexity. https://biomedpharmajournal.org/vol18no4/development-and-validation-of-pentoxifylline-ptx-pictogram-based-drug-information-leaflet-p-dil/ Development Information leaflet Pentoxifylline Pictogram Validation