A concept paper published today by NEJM Catalyst details how a new Innovative Medicines Initiative project, Health Outcomes Observatory (H20) will establish the largest-ever ecosystem for incorporating patient-reported and other health outcomes into healthcare decision-making across multiple European countries. The paper, “Building a Value-Based Care Infrastructure in Europe: The Health Outcomes Observatory,” is available on the NEJM Catalyst Innovations in Care Delivery journal website.
Key points from the paper include:
- While it is known that patient involvement in care and routine collection of patient-reported outcomes (PROs) can influence the experience of care and even clinical outcomes, there are currently few examples of patient-focused value assessments used at scale.
- The H2O project directly addresses this gap by establishing standardised collection of PROs, starting in four countries and three disease areas (diabetes, inflammatory bowel disease and cancer), and by creating an ethical and socially responsible data governance system providing access to health data to stakeholders with legitimate interests.
- Health data, made up of both PROs and other health outcomes, are an essential resource for society, enabling innovation in research and the development of new treatments, devices, products, and therapies that will improve care for individuals and for entire health systems.
- In the H2O Observatory model, patients are data controllers. Because patient engagement is critical, patients and patient representatives are involved in the project at all levels.
This publication also reports the results of the project’s first Delphi exercise, which established a multi-stakeholder consensus on the methodology to appraise and select core outcome sets in a way that ensures broad acceptability, ensuring meaningful outcome measurements at scale.
- The goal of the Delphi process is to identify practical and patient-friendly solutions to enable patients to record and report outcomes and side effects with minimum effort.
- H2O’s specific focus is the feasibility of implementation of the outcomes, the user-friendliness of the methodology, the possibility for independent reporting by patients, and the ability to leverage technologies.
- This process is currently underway in the three disease-specific working groups, with their Delphi studies soon to be launched.
Please revisit this website for regular updates on the progress of the H2O project.
Read the full paper at https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0146.