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).

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.

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.

The module was refined iteratively, using qualitative and quantitative insights at each phase of development. The model was only finalised after thorough content validation.

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.

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.

The objective of this scoping review is to elucidate contexts in which Flexible Assertive Community Treatment (FACT) has been utilised, which populations it has served, how it has been adapted and what outcomes it has achieved. FACT is a model of mental healthcare where patients are transitioned along a continuum of high-intensity outreach-based treatment and lower-intensity case management, according to need. Despite being adopted globally, a review of the evidence on the FACT model has not been conducted since 2014.

This study will follow the Joanna Briggs Institute’s (JBI) methodology for scoping reviews and the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. A structured search of several electronic databases (MedLine, CINAHL, PsycINFO, Psychology & Behavioural Sciences, Embase, Scopus, Sociological Abstracts and ASSIA Social Sciences Index Abstracts) will be conducted to locate relevant studies addressing models of care that adhere to the core components of the FACT model and that were published in English or Dutch from 2003 (model conception date) to the present day. To explore the range of populations served by FACT, we will not limit participant populations by age or diagnosis. With respect to FACT adaptations, we will include articles that explore modifications to the structure of FACT such as staffing complement, caseloads or interface with other health and social services. Articles identified from our structured searches will be screened independently by two reviewers. Data from included articles will be extracted, analysed and presented on tables and visual graphs, and summarised in a narrative report.

Our scoping review does not require ethics approval as it does not involve human subjects and will draw evidence from published peer-reviewed articles. Our findings will be disseminated through journal publication, presentations at relevant conferences and distribution across our networks and those of our partners, including healthcare providers, researchers and other key stakeholders.