Abstract
OBJECTIVES: To generate an algorithm for systematic development and validation of written patient information in accordance with well-established and validated psychometric and statistical methods that can be applied to different fields of medicine. METHODS: A literature search was carried out in PubMed and Google Scholar. Methods were selected and combined to an algorithm. Feasibility and practicability is tested by the development of patient education materials on "ureteral stenting". RESULTS: The algorithm includes 4 study phases. After internal audit expert, readability of the first version is objectified using the Flesch Reading Ease formula. This draft is tested by a few patients performing semi-structured interviews using "The think aloud method" by Someren et al. Content validity is evaluated by a written survey by external consultants in accordance with Lawshe's "Quantitative approach to content validity". The final leaflet is developed at a consensus meeting and validated by patients based on the Consumer Information Rating Form. The new algorithm could be tested by the development of patient education materials on "ureteral stenting" as a test run. CONCLUSION: We developed an algorithm for systematic development and validation of written patient information in accordance with well-established, validated psychometric and statistical methods. This algorithm can be applied to arbitrary fields of medicine.