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.

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Background Inadequate drug monitoring of drug therapy after hospital discharge facilitates adverse drug events and preventable hospital readmissions. Objective This study aimed to analyze the structure and content of drug monitoring advices of a representative sample of discharge letters as a basis for future electronic information systems. Methods On 2 days in November 2016, all discharge letters of 3 departments of a university hospital were extracted from the hospital information system. The frequency, content, and structure of drug monitoring advices in discharge letters were investigated and compared with the theoretical monitoring requirements expressed in the corresponding summaries of product characteristics (SmPC). The quality of the drug monitoring advices in the discharge letters was rated with the domains of an adapted systematic instructions for monitoring (SIM) score. Results In total, 154 discharge letters were analyzed containing 1180 brands (240 active pharmaceutical substances), of which 50.42% (595/1180) could theoretically be amended with a monitoring advice according to the SmPC. In reality, 40 discharge letters (26.0%, 40/154) contained a total of 66 monitoring advices for 57 brands (4.83%, 57/1180), comprising 18 different monitoring parameters. Drug monitoring advices only addressed mean 1.9 (SD 0.8) of the 7 domains of the SIM score and frequently did not address reasons for monitoring (86%, 57/66), the timing of monitoring, that is, the start (76%, 50/66), the frequency (94%, 63/66), the stop (95%, 63/66), and how to react (83%, 55/66). Conclusions Drug monitoring advices were mostly absent in discharge letters and a gold standard for appropriate drug monitoring advices was lacking. Hence, more effort should be put in the development of tools that facilitate easy presentation of clinically meaningful drug monitoring advices at the point of care.