Development of a patient decision aid for prevention of myocardial infarction in type 2 diabetes – rationale, design and pilot testing

AIMS Development and testing of a decision aid about prevention of myocardial infarction for persons with type 2 diabetes. METHODS Development and testing were guided by the UK Medical Research Council's guidance for the development and evaluation of complex interventions. This comprised a systematic literature review, a focus group of 9 potential providers, modelling a prototype, interviews to qualitatively explore understanding and additional information needs, and revision of the decision aid. RESULTS The decision aid includes evidence-based information, a tool for individual risk-assessment, worksheets, and an action plan. Five diabetes educators and 15 patients underwent two 60-minutes face-to-face interviews, firstly browsing the decision aid for the first time and then after using it. Both groups differed in their ratings. Overall, the decision aid was rated to present essential information in a complex but understandable and unbiased manner. Difficulties involved understanding of terminology and risk interpretation. "Social status as a risk factor" was the most challenged content by educators but considered as highly important by patients. The risk assessment tool was used inadequately. 5 patients allocated themselves into false risk categories. After revision of the tool, all 12 patients who were recruited for reassessment used the tool correctly. CONCLUSION The decision aid was evaluated with diabetes educators and patients. Qualitative data analysis revealed aspects for revision. The decision aid is planned to be part of a shared decision making programme, comprising a strategy for patient counselling and educational modules addressed to providers. Quantitative evaluation is required to assess its effectiveness.