Proposal for a new study design and endpoint in research on medication history taking.

Introduction: Medication history errors at hospital admission are common and effective strategies to improve the quality of medication histories are still being researched. However, studies on new approaches regarding medication history taking are often time-consuming and resource-intensive. The gold standard when evaluating the quality of medication histories is the comparison of a Best Possible Medication History to the original. However, this double collection requires significant resources, disrupts clinical procedures, and places an additional burden on patients. Therefore, more efficient study designs need to be explored. We aimed to develop a design for future studies on medication history taking that uses fewer research resources and places less strain on patients and staff.

Discussion: We first identified shortcomings of the established study designs on medication history taking and subsequently defined requirements for a new design. A pragmatic study with an alternative endpoint was identified in a previous literature search. It served as the starting point from which we developed a new study design to assess the quality of approaches to medication history taking. Instead of taking a second medication history, a patient's pre-existing medication document can be used as comparator to determine the quality of the medication history. Furthermore, we defined a new primary endpoint, i.e. the number of updates per patient. Updates are differences between the newly acquired medication history and the comparator. They include discontinued, initiated, and changed medications. To enhance our proposed design, we recommend a preparatory phase to identify a suitable comparator document, and a baseline phase to assess the current process.

Conclusion: We propose a more resource-efficient study design with a new endpoint. We plan to test its feasibility and evaluate whether it could enhance the efficacy of research on medication history taking in a pilot project.