The first round of meetings for the CARAMEL Public and Patient Involvement (PPI) Committees has officially begun across Europe and Latin America. Hosted by leading clinical and research partners, these local committees are designed to ensure that CARAMEL’s tools and strategies are co-created with direct input from those most affected: women aged 40–60 going through menopause, alongside the healthcare professionals who support them.

By involving both groups from the earliest stages, the PPI Committees play a vital role in shaping the project’s approach to cardiovascular risk prevention. They contribute to defining priorities, identifying practical needs, and validating the usability and relevance of digital solutions, such as the CARAMEL App, AI-based risk models, and self-management tools. This inclusive, participatory process strengthens CARAMEL’s goal to deliver real-world impact, bridging clinical innovation with lived experience.

On 12 July 2025, Trinity College Dublin (TCD) launched its PPI Committee within the CARAMEL project. The inaugural hybrid meeting brought together 12 participants, including researchers and women with lived experience, under the expert guidance of Professor Sharon O’Donnell.

At the core of the discussion was the collaborative development of the CARAMEL heart health App. While a basic framework is already in place, participants unanimously stressed the need for iterative input from women through surveys, interviews and direct engagement. This participatory approach ensures the final App will include meaningful features, intuitive design, and accessible content that truly responds to women’s needs during midlife and menopause.

The meeting also explored the potential for integrating the App into Ireland’s Health Service Executive (HSE) digital infrastructure, especially platforms currently under trial. However, sustainability beyond the project’s five-year timeline raised important questions around future maintenance, commercialization, and regulatory classification as a potential medical device.

Structured feedback mechanisms were identified as essential to app testing. Participants emphasized the importance of clear guidance and realistic timelines to ensure meaningful, informed contributions. The developers were encouraged to provide ongoing support as the co-design process evolves.

A key outcome was the group’s decision to formally adopt the term PPI Committee instead of the previously used “End-User Committee.” This shift reflects their broader role, not only in shaping the App, but in influencing the project’s research, outreach, and educational components.

Another PPI Committee meeting took place in Seville, led by Servicio Andaluz de Salud (SAS) and Fundacion Publica Andaluza para la gestion de la investigacion en salud de Sevilla (FISEVI), with a strong emphasis on personal stories and inclusivity. Participants, researchers, and facilitators came together to introduce the CARAMEL project, exchange personal stories, and discuss the transformative potential of their involvement.

The meeting was warmly received, with participants expressing deep enthusiasm and gratitude for the opportunity to shape a project with real-world impact. Several women shared personal and second-hand experiences related to menopause and cardiovascular disease, reinforcing the urgency and relevance of CARAMEL’s mission.

Looking ahead, the committee showed strong interest in contributing to the upcoming CARAMEL-OS clinical study, set to launch in January 2026. Their involvement will be instrumental in refining recruitment strategies and identifying challenges early in the process.

Significantly, the committee also raised the need to better represent marginalised communities, especially African immigrant populations often underrepresented in clinical studies. This important recommendation will be carried forward to future discussions.

On 13 October 2025, a CARAMEL PPI Committee meeting took place at Aretaieion Hospital in Athens, bringing together menopausal women, endocrinologists, and researchers from Ethniko Kai Kapodistriako Panepistimio Athinon (NKUA) to discuss cardiovascular health risks during menopause and the structural challenges women face in accessing care.

The session revealed a wide range of symptoms such as hot flashes, palpitations, and metabolic disturbances, that are often underrecognized or dismissed in clinical settings. Many participants said they had not been aware of the cardiovascular implications of these symptoms until receiving specialised care. Clinical experts emphasised the need for interdisciplinary collaboration, especially with cardiology, and more comprehensive screening practices.

The discussion also exposed systemic gaps, including the lack of specialised menopause clinics (particularly in rural areas), insufficient cross-disciplinary training for clinicians, and cultural taboos that limit women’s willingness to discuss symptoms openly.

The group provided valuable feedback on the CARAMEL digital App, recommending features like symptom tracking, wearable integration, alerts, lifestyle coaching, mental health support, educational content, and secure communication with doctors. They stressed the importance of simplicity, trustworthiness, and accessibility, particularly for women in underserved areas.

This meeting reinforced the CARAMEL project’s mission to co-create inclusive, AI-powered prevention tools while also addressing structural health inequities and knowledge gaps.

The first PPI Committee meeting at Magdalena Clinic took place on 21 October 2025 in Krapinske Toplice, Croatia, with some participants attending in person and others joining online, enabling broad participation despite logistical constraints. The meeting brought together a group of seven people, including women from the project’s target group as well as clinicians, two doctors and two nurses.

The session introduced participants to the CARAMEL project and the purpose of the PPI committee, setting the stage for future collaboration. Participants expressed strong interest in the upcoming phases of the project and particularly the joint testing and evaluation of the CARAMEL mobile App.

Attendees shared valuable suggestions for the App’s features and expressed enthusiasm about contributing to its development and broader dissemination. The hybrid setup proved effective in accommodating diverse schedules, and participants voiced interest in reconvening soon for continued input.

This first meeting reaffirmed Magdalena Clinic’s commitment to user engagement and demonstrated the project’s ability to reach and activate diverse voices across the region.

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