gms | German Medical Science

Background/research question: Patient-centered decision-making in preventive medicine involves the consideration of an individual's baseline risks for disease, expected treatment effects and outcomes, and personal preferences. Whether a treatment ultimately provides a net benefit strongly depends on the balance of expected benefits and potential harms resulting from these factors. However, preventive guidelines commonly fail to transparently consider all these aspects and fall short of providing clinicians with evidence that is ready to be used in clinical encounters. Patient decision aids (PtDAs) have been shown to benefit medical decision-making in practice, but have not previously combined an individual risk calculation for all important outcomes, the elicitation of preferences and a benefit-harm assessment in one tool.

Methods: We developed a novel PtDA for low-dose aspirin as a primary preventive treatment for cardiovascular disease. The development process included a systematic review of the available evidence, the selection of the most applicable, valid and precise evidence for the Swiss population, the design and iterative adaptation of the PtDA, and the testing of the PtDA with potential users. A model was incorporated that estimates the individual 10-year risk for cardiovascular disease, major bleeding and colorectal cancer, and calculates a weighted benefit-harm balance index.

Results: Our innovative PtDA combines patient information, an individual risk calculator and a preference elicitation task with a quantitative benefit-harm assessment. By providing an estimation of the individual balance of benefits and harms of low-dose aspirin, the PtDA showed a large potential as a tool for making individual treatment recommendations in clinical practice. While the PtDA remains to be tested in a randomized controlled trial setting, feedback from potential users in a first testing round was positive. The testing of the PtDA confirmed that the balance of benefits and harms in this context strongly depends on patient preferences.

Conclusion: Incorporating preference-informed benefit-harm assessments in a PtDA may be an effective way of providing clinicians with evidence-based and readily interpretable information to support individual decision-making in preventive settings.

Competing interests: We declare to have no conflicts of interest.