Periodic Reporting for period 4 - H2O (H2O Health Outcomes Observatory)
Période du rapport: 2023-10-01 au 2024-09-30
Patients' health outcomes and their experience of healthcare could be substantially improved through the systematic capture of data. However, there is a lack of standardisation, interoperability and implementation of outcome measurement schemes in many countries, and we do not yet fully use the information collected from patient-reported outcomes. We are working to address this urgent unmet need of a European-scale network of outcomes data collection, analysis and evidence sharing to inform clinical practice and healthcare decisions. To tackle these issues, this public-private consortium has set up independent, patient-centred Health Outcomes Observatories (H2Os) in four European countries, initially focused on three diseases. We have standardised health outcomes measurement points based on the input of all relevant stakeholders, including patients, healthcare providers, scientists, healthcare decision makers, technology providers and industry representatives. The Observatories have been created based on a multi-stakeholder governance model that allows for ethically and legally appropriate data sharing; furthermore, we have developed a Patient Agreement to empower patients through self-management of their data. The Observatories are working to equip patients and clinicians with tools to measure and visualise these outcomes including standardised questionnaires and new technologies. Based on a hybrid model of federated and centralised data management and analysis, health data remain safely protected under national law. The National Observatories work together with a Pan-European H2O to facilitate interoperability, guide reproducibility in other countries, and promote the benefit of measuring and using patient-centred outcomes at regional, national, European and global levels.
• The concept of the project has been published (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0146(s’ouvre dans une nouvelle fenêtre)) as well as a white paper on H2O and Value-Based Healthcare (https://health-outcomes-observatory.eu/wp-content/uploads/2023/10/The-Health-Outcomes-Observatory-The-Power-of-Patient-Reported-Outcomes.pdf(s’ouvre dans une nouvelle fenêtre)) and a white paper on the value of trust in healthcare data management and access (https://health-outcomes-observatory.eu/wp-content/uploads/2023/10/The-Health-Outcomes-Observatory-The-Power-of-Patient-Reported-Outcomes.pdf(s’ouvre dans une nouvelle fenêtre)).
• We conducted public webinars on health data governance as well as the importance of patient-reported outcomes (PROs) in patient-centric care. We have also hosted two hybrid events highlighting (1) H2O as it relates to the European Health Data Space, and (2) the need to expand use of PROs beyond clinical trials to clinical practice. National patient outreach events have taken place in all the participating countries, some in collaboration with the European Patients’ Forum and Data Saves Lives.
• We developed a constitution document for the national observatories and founded the legal entities in all four countries based on a governance model with equal stakeholder involvement.
• A large number of external participants, including patients and opinion leaders from the three diseases, took part in the Delphi studies to define the outcomes that we will measure. The resulting Core Outcome Sets have all been published in scientific journals: Diabetes literature review (https://doi.org/10.1016/j.pec.2023.107933(s’ouvre dans une nouvelle fenêtre)) Diabetes Delphi study (https://doi.org/10.1111/dme.15259(s’ouvre dans une nouvelle fenêtre)) IBD Delphi study (https://doi.org/10.1093/ecco-jcc/jjad195(s’ouvre dans une nouvelle fenêtre)) Metastatic Breast Cancer Delphi study (https://doi.org/10.1007/s10549-022-06827-6(s’ouvre dans une nouvelle fenêtre)) and Lung Cancer Delphi study (https://doi.org/10.1016/j.lungcan.2022.08.021(s’ouvre dans une nouvelle fenêtre)).
• Patients have been recruited in all the participating countries.
• A feasibility study is being conducted to investigate uptake of the H2O patient outcomes and technology usage, and interim analyses have been produced.
• An architecture model for the technical infrastructure of H2O has been designed. Initial and long-term technology solutions for the capture and display of outcomes, and overall data management and access for research are being identified by all of the participating centres.
• A call for expressions of interest for (external) technology providers to partner with H2O at the project level was made and a webinar was conducted to inform about this call. 47 attendees from 25 companies/institutions expressed interest to collaborate with H2O. Each country is working on individualised internal and external technology solutions for data collection and visualisation, and backend management.
• A call was launched to find a place/host country for the Pan-EU Observatory. A Collaboration Agreement was signed with Aarhus University Hospital in Denmark to establish this and additionally join Denmark to H2O. The Pan European Observatory was established.
• A Collaboration Agreement was signed with the International Consortium for Health Outcomes Measurement (ICHOM) to work together on standardising and implementing outcomes measurement. ICHOHM accredited the H2O Metastatic Breast Cancer outcome set.
• An H2O Patient Agreement was developed with patients to manage the consent process and empower patients with control over their own health data (https://health-outcomes-observatory.eu/h2o-patient-agreement/(s’ouvre dans une nouvelle fenêtre)).
• The H2O Insights Centre provides a public snapshot of aggregated patient demographic data from the National Observatories, accessible from the H2O website.
• Outreach and communications efforts have established a strong multi-stakeholder community dedicated to promoting the patient voice and improving patient outcomes.
• We conducted public webinars on health data governance as well as the importance of patient-reported outcomes (PROs) in patient-centric care. We have also hosted two hybrid events highlighting (1) H2O as it relates to the European Health Data Space, and (2) the need to expand use of PROs beyond clinical trials to clinical practice. National patient outreach events have taken place in all the participating countries, some in collaboration with the European Patients’ Forum and Data Saves Lives.
• We developed a constitution document for the national observatories and founded the legal entities in all four countries based on a governance model with equal stakeholder involvement.
• A large number of external participants, including patients and opinion leaders from the three diseases, took part in the Delphi studies to define the outcomes that we will measure. The resulting Core Outcome Sets have all been published in scientific journals: Diabetes literature review (https://doi.org/10.1016/j.pec.2023.107933(s’ouvre dans une nouvelle fenêtre)) Diabetes Delphi study (https://doi.org/10.1111/dme.15259(s’ouvre dans une nouvelle fenêtre)) IBD Delphi study (https://doi.org/10.1093/ecco-jcc/jjad195(s’ouvre dans une nouvelle fenêtre)) Metastatic Breast Cancer Delphi study (https://doi.org/10.1007/s10549-022-06827-6(s’ouvre dans une nouvelle fenêtre)) and Lung Cancer Delphi study (https://doi.org/10.1016/j.lungcan.2022.08.021(s’ouvre dans une nouvelle fenêtre)).
• Patients have been recruited in all the participating countries.
• A feasibility study is being conducted to investigate uptake of the H2O patient outcomes and technology usage, and interim analyses have been produced.
• An architecture model for the technical infrastructure of H2O has been designed. Initial and long-term technology solutions for the capture and display of outcomes, and overall data management and access for research are being identified by all of the participating centres.
• A call for expressions of interest for (external) technology providers to partner with H2O at the project level was made and a webinar was conducted to inform about this call. 47 attendees from 25 companies/institutions expressed interest to collaborate with H2O. Each country is working on individualised internal and external technology solutions for data collection and visualisation, and backend management.
• A call was launched to find a place/host country for the Pan-EU Observatory. A Collaboration Agreement was signed with Aarhus University Hospital in Denmark to establish this and additionally join Denmark to H2O. The Pan European Observatory was established.
• A Collaboration Agreement was signed with the International Consortium for Health Outcomes Measurement (ICHOM) to work together on standardising and implementing outcomes measurement. ICHOHM accredited the H2O Metastatic Breast Cancer outcome set.
• An H2O Patient Agreement was developed with patients to manage the consent process and empower patients with control over their own health data (https://health-outcomes-observatory.eu/h2o-patient-agreement/(s’ouvre dans une nouvelle fenêtre)).
• The H2O Insights Centre provides a public snapshot of aggregated patient demographic data from the National Observatories, accessible from the H2O website.
• Outreach and communications efforts have established a strong multi-stakeholder community dedicated to promoting the patient voice and improving patient outcomes.
H2O has started:
• Delphi processes in all three disease areas including a generic process,
• Multi stakeholder involvement at all levels within the governance structure and set-up,
• Set up the national observatories as self-sustaining entities that will attract additional funding,
• Establishment of the Pan-European Observatory in Denmark and
• Decided to launch an H2O Forum to guide innovation in the future.
• Through the Delphi studies, a consensus on outcomes was achieved between patients, providers/researchers, regulators and industry. Patients have been recruited in all H2O countries. Negotiations with existing large-scale data sources are underway in each country. Alignment meetings between the four Tier One Countries regularly take place. Each country has developed a tailored method to work with internal and/or external technology providers regarding the patient-facing data collection as well as the backbone of the platform. Alignment meetings take place with other similar initiatives and other projects.
• Ongoing communication and outreach efforts with EU and national representatives present H2O as a trial for the EHDS.
• Including patients in the definition of the outcomes that matter most to them and systematically incorporating collection and use of patient-reported outcomes into routine care empowers patients in a way never before attempted at this scale.
• Through the standardised collection and analysis of both clinical and patient-reported health outcomes across multiple European countries and diseases, quality of care and overall outcomes will be improved for individual patients and for populations.
• Delphi processes in all three disease areas including a generic process,
• Multi stakeholder involvement at all levels within the governance structure and set-up,
• Set up the national observatories as self-sustaining entities that will attract additional funding,
• Establishment of the Pan-European Observatory in Denmark and
• Decided to launch an H2O Forum to guide innovation in the future.
• Through the Delphi studies, a consensus on outcomes was achieved between patients, providers/researchers, regulators and industry. Patients have been recruited in all H2O countries. Negotiations with existing large-scale data sources are underway in each country. Alignment meetings between the four Tier One Countries regularly take place. Each country has developed a tailored method to work with internal and/or external technology providers regarding the patient-facing data collection as well as the backbone of the platform. Alignment meetings take place with other similar initiatives and other projects.
• Ongoing communication and outreach efforts with EU and national representatives present H2O as a trial for the EHDS.
• Including patients in the definition of the outcomes that matter most to them and systematically incorporating collection and use of patient-reported outcomes into routine care empowers patients in a way never before attempted at this scale.
• Through the standardised collection and analysis of both clinical and patient-reported health outcomes across multiple European countries and diseases, quality of care and overall outcomes will be improved for individual patients and for populations.