Periodic Reporting for period 3 - H2O (H2O Health Outcomes Observatory)
Período documentado: 2022-10-01 hasta 2023-09-30
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 these outcomes. Based on a hybrid model of federated and centralised data management and analysis, health data will be remain safely protected under national law. The national Observatories will be connected to a Pan-European umbrella 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) 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).
• 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.
• 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) Diabetes Delphi study (https://doi.org/10.1111/dme.15259) IBD Delphi study (https://doi.org/10.1093/ecco-jcc/jjad195) Metastatic Breast Cancer Delphi study (https://doi.org/10.1007/s10549-022-06827-6) and Lung Cancer Delphi study (https://doi.org/10.1016/j.lungcan.2022.08.021).
• First patients have been recruited in Germany and Austria, with clinical teams in all countries prepared to recruit soon.
• 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.
• 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.
• 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/).
• 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.
• 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) Diabetes Delphi study (https://doi.org/10.1111/dme.15259) IBD Delphi study (https://doi.org/10.1093/ecco-jcc/jjad195) Metastatic Breast Cancer Delphi study (https://doi.org/10.1007/s10549-022-06827-6) and Lung Cancer Delphi study (https://doi.org/10.1016/j.lungcan.2022.08.021).
• First patients have been recruited in Germany and Austria, with clinical teams in all countries prepared to recruit soon.
• 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.
• 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.
• 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/).
• H2O has started:
o Delphi processes in all three disease areas including a generic process,
o Multi stakeholder involvement at all levels within the governance structure and set up,
o Set up the national observatories as self-sustaining entities that will attract additional funding,
o Establishment of the Pan-European Observatory in Denmark and
o 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. Data collection has started with the first patients included in H2O. Negotiations with existing large-scale data sources have started in each country. Alignment meetings between the four Tier One Countries regularly take place. The decision has been made to also work with external technology providers regarding the patient-facing data collection as well as the backbone of the platform. Alignment meetings taken place with other similar initiatives and other projects.
• 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.
o Delphi processes in all three disease areas including a generic process,
o Multi stakeholder involvement at all levels within the governance structure and set up,
o Set up the national observatories as self-sustaining entities that will attract additional funding,
o Establishment of the Pan-European Observatory in Denmark and
o 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. Data collection has started with the first patients included in H2O. Negotiations with existing large-scale data sources have started in each country. Alignment meetings between the four Tier One Countries regularly take place. The decision has been made to also work with external technology providers regarding the patient-facing data collection as well as the backbone of the platform. Alignment meetings taken place with other similar initiatives and other projects.
• 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.