Guidance on how to achieve comprehensible patient information leaflets in four steps.

Comprehensible information leaflets can improve a patient's knowledge. However, in clinical studies leaflets are often introduced without meticulously verifying their comprehensibility. In an attempt to provide a feasible guidance on how to design comprehensible leaflets we complied and evaluated an easy-to-use development procedure. In January 2015, a literature search was performed to identify evidence for readily available quality assurance strategies as a starting point for a standardized strategy to develop and validate written patient information. The suggested development strategy is a consecutive four-step procedure that comprised already validated distinct quality assessments: (i) an initial requirement analysis specifying the needs and constraints of the target population and evidence-based preparation of the leaflets, (ii) a readability assessment, (iii) the Suitability Assessment of Materials instrument and (iv) iterative consumer test in the target population. The consecutive combination of pertinent and previously validated quality assessments provides an easy-to-use guidance on how to create comprehensibly written patient information, particularly for small-scale research projects with time and money constraints.