Capturing risk awareness and disease burden in cardiovascular (risk) management: development and content validation of a new module for the Assessment of Burden of Chronic Conditions (ABCC)-tool

Objectives Cardiovascular disease (CVD) is the leading cause of death worldwide and is associated with a broad range of physical, emotional and social burdens. Existing tools such as Systematic Coronary Risk Evaluation and WHO CVD risk charts identify clinical risk factors but fail to capture patient-perceived burden and the risk of burden awareness. The Assessment of Burden of Chronic Conditions (ABCC)-tool, a validated, person-centred instrument, offers a more holistic approach. The aim of the current study is to develop and validate a new module within the ABCC-tool for patients with an elevated cardiovascular (CV) risk or CVD (cardiovascular risk management (CVRM) module). Design and setting A mixed-methods design was used across four phases and expert meetings to identify the items for the module. All phases took place in the Netherlands. Phase 1 (literature search) was performed in 2021, phase 2 (semistructured interviews) was completed between January and October 2021, phase 3 (survey) was completed in November 2023 and December 2024, and phase 4 (semistructured interviews) was completed in January 2025. Participants Phase 2 involved 14 experts by experience (patients with CVD or people at elevated risk) and 10 healthcare professionals in the field of CVD. Phase 3 included 86 healthcare professionals. Phase 4 included 12 experts by experience. In total, four expert meetings took place, attended by three experts by experience, nine healthcare professionals and seven researchers. Outcome measures The module was refined iteratively, using qualitative and quantitative insights at each phase of development. The model was only finalised after thorough content validation. Results No suitable patient-reported outcome measures (PROMs) focusing specifically on CVRM were identified in the literature. Interviews revealed significant burdens in terms of physical, emotional and social burdens. Feedback from expert meetings and validation rounds led to substantive refinement. The final module contains 10 items and was deemed valid by both experts by experience and healthcare professionals. Conclusion The CVRM module of the ABCC-tool has been systematically developed and validated in terms of content. The final module focuses on the multidimensional burden of CVD and dealing with its risk factors and aims to support self-management. The module complements existing risk assessment tools by focusing on the burden experienced by the patient and the burden resulting from risk awareness.