Framework to IMPROVE the Integration of Patient Generated Health Data to Facilitate Value Based Healthcare

Project Information

IMPROVE

Grant agreement ID: 101132847

DOI

10.3030/101132847

EC signature date 10 November 2023

Start date 1 December 2023

End date 30 November 2028

Funded under

• Health

Total cost

€ 17 115 898,05

EU contribution

€ 10 313 760,50

Coordinated by

UNIVERSIDAD POLITECNICA DE MADRID
Spain

Periodic Reporting for period 2 - IMPROVE (Framework to IMPROVE the Integration of Patient Generated Health Data to Facilitate Value Based Healthcare)

Reporting period: 2024-12-01 to 2025-11-30

Summary of the context and overall objectives of the project

IMPROVE will use Patient Generated Health Data (PGHD) gathered via m-health and e-health technologies to gain improved insights into the real-life behavior of, and challenges faced by, patients of all ages with complex, chronic diseases and comorbidities. Already today, a wealth of patient and citizen information is available, but fragmented, and therefore not coming to its full utility and value. These personal data will complement and improve existing approaches for Patient-Centered Outcome Measures beyond those currently available in state-of-the-art platforms. The IMPROVE platform that the consortium will build will enable the smart use of patient input and patient generated evidence to 1) advance the role of patient preference and patient experience in the context of treatment selection, 2) improve medical device design based on patient preferences and experiences, and 3) facilitate faster market entry of patient-centric and cost-effective advanced integrated care solutions. Improved clinical adoption of Value Based Health Care, and enhanced return on research and innovation investments will be demonstrated in different care settings across the EU, for 10 use cases in at least 5 different disease areas (e.g. ophthalmology, oncology, cardiovascular disease, chronic inflammation, and neurology). The use cases will be conducted using a large variety of implementation strategies, building on a design thinking approach, to optimally test the innovative framework of data gathering and translation into controlled change and action. In addition, a significant contribution from implementation science is planned to reach out to all stakeholders that are relevant for this initiative and maximise the impact to IMPROVE healthcare provision. (Website: https://www.ihi-improve.eu)

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During year 2, the IMPROVE project transitioned from foundational design and methodological definition to technical operationalization and initial real-world validation. The consortium achieved critical milestones in the deployment of the platform, the harmonization of health datasets, and the activation of clinical pilot sites.
The technical core of the project, driven by WP3 and WP4, made significant progresses in operationalizing the data integration layer. Diverse real-world datasets were successfully harmonized using HL7-FHIR standard to ensure semantic interoperability. Technical implementation was validated through Proofs of Concept (PoCs), specifically utilizing the Picasso ETL tool for automated data modeling and the CKP platform for the formalization of clinical guidelines. The needs and methodologies for additional data collection were defined (D4.1) and the update and maintenance of the platform were implemented (D3.6 D3.10). The IMPROVE dashboard also reached a mature design phase, moving from functional requirements to high-fidelity mock-ups and initial prototyping (D3.8 D3.9).
Supporting these technical advancements, the IMPROVE knowledge warehouse (WP2) was significantly expanded through a 2nd Screenathon event. This human–AI collaborative screening of over 12000 meta-analyses facilitated the preparation of updated systematic review reports (D2.3) and the identification of real-world practices for PGHD collection (D2.7). To enhance sustainability, the project initiated the use of Large Language Models (LLMs) to automate the monitoring of emerging scientific and policy trends.
In terms of stakeholder engagement, WP6 finalized the co-creation process by conducting 33 in-depth interviews with patients, clinicians, and researchers. This process led to the structured assessment of stakeholder requirements (D6.1) and a systematic fit assessment (D6.2) to evaluate the alignment between stakeholder needs and the project’s technical tools. All technical and clinical activities were conducted under the updated ethical and data protection framework reported in D1.7.
A major operational milestone was reached by WP5, which moved from pilot design into the active implementation phase. With 90% of study designs and ethical approvals secured across multiple pilot sites.
Finally, the project’s strategic reach was expanded through the activities of WP8. The consortium established an Exploitation Working Group to drive the long-term vision of the framework toward Value-Based Healthcare (VBHC), identifying potential Key Exploitable Results (KERs).

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Main results beyond the state of the art achieved during year 2 of the project:
• Advanced the Screenathon methodology by screening over 12000 meta-analyses using ASReview V2, proposing a novel scientific standard for rapidly synthesizing large-scale evidence and formalizing a well-curated knowledge warehouse in the project.
• Initiated the use of Large Language Models (LLMs) to automate the monitoring of emerging scientific, practice, and policy trends, ensuring the IMPROVE knowledge warehouse remains dynamic and state-of-the-art.
• Developed and implemented a shared data model based on HL7 FHIR that ensures interoperability for heterogeneous datasets across diverse clinical partners and therapeutic areas.
• High-fidelity mockups for the IMPROVE data dashboard were developed and validated based on co-design sessions and Quintuple Helix requirements mapping, and the MVP development was initiated during this period.
• Progressed beyond initial pilot design into operational execution, advancing from high-level UC definition to the granular structuring of patient pathways and systematic selection of PREMs, PROMs, and PPIs across care stages, establishing an implementation-ready, patient-centred performance framework beyond current practice.
• Completed a systematic evaluation of the alignment between identified stakeholder values (from 33 in-depth interviews) and the project’s technical tools to ensure user-centricity and future adoption.