H2O Health Outcomes Observatory

Informazioni relative al progetto

H2O

ID dell’accordo di sovvenzione: 945345

DOI

10.3030/945345

Data della firma CE 30 Settembre 2020

Data di avvio 1 Ottobre 2020

Data di completamento 31 Marzo 2026

Finanziato da

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Costo totale

€ 22 741 030,99

Contributo UE

€ 10 476 687,45

Coordinato da

MEDIZINISCHE UNIVERSITAET WIEN
Austria

CORDIS fornisce collegamenti ai risultati finali pubblici e alle pubblicazioni dei progetti ORIZZONTE.

I link ai risultati e alle pubblicazioni dei progetti del 7° PQ, così come i link ad alcuni tipi di risultati specifici come dataset e software, sono recuperati dinamicamente da .OpenAIRE .

Risultati finali

Documents, reports (30)

Repository of use cases of the Observatories

Repository of use cases use cases developed in collaboration with WP2 that will serve to provide examples of use of the Observatories.

Report on requirements specification

Report including specification for digital technology selection, adaptation and/or development produced in collaboration with Work Packages 2 and 5.

Assessment of the local and national situation

The resulting report will describe the regulatory frameworks underlying the architectural design, which is developed in parallel.

Second annual report on the progress and success of Observatories

Annual report of the second year of operation of the Observatories.

Development of a cross-calibration method to be used in all three disease areas, and exploration of a cross-calibration approach between all core outcome sets and PRO tools

This specification of cross-calibration approaches will support the interoperability of core outcome sets collected in the various disease areas.

Data and evidence quality assessment and labelling methodology

Methodology to assess the reliability of H2O outcomes by assessing data quality and the data processing by H2O systems.

Stakeholder value propositions and sustainability success factors

Consensus value propositions and incentives most likely to secure endorsement and investment by key stakeholders

First report on the implementation of Diabetes, IBD and Cancer Treatment core outcome sets

FFirst, preliminary report on Diabetes, IBD and Cancer Treatment core outcome set implementation with recommendations for updating core outcome set in Tier One Countries.

Development of core elements of stakeholder-centric reports

These core elements will form the basis of the stakeholder-centric reports created in two iterations.

Project KPIs and success metrics

List of agreed Key Performance Indicators and how they will be measured and tracked throughout the project, and KPIs for the H2O solution.

Bylaws of the Patient Advisory Boards

Terms of reference and principles for the selection of participants, operation and governance of PABs in the three disease specific WPs.

Scientific publication plan

Plan development to support and promote scientific publications and participation in conferences.

Data Management Plan v1 including first version of master informed consent

Intended data sources, processing, adoption of FAIR principles and potential shareability of data post-project.

Development of an architecture blueprint

The architecture blueprint will guide the development of local, regional, national and European infrastructure components developed iteratively throughout the project.

H2O information governance and ethics framework

Portfolio of instruments and codes of practice to ensure GDPR compliance and ethical handling of outcomes data.

Operational plans for the Pan-European Umbrella Observatory

Operational plan containing description of main actions required for the deployment and functioning of the Pan European Observatories.

Deployment of the first version of stakeholder-centric reports

This initial version of the stakeholder-centric reports provided, will focus on informing physicians and patients.

Material for clinical implementation

This will include educational material and recommendations for patient recruitment and physician engagement

Report on educational strategies and material

Educational material for clinical implementation, including strategies for patient participation and physician engagement.

Project Handbook

Quick reference manual for partners to consult management procedures, including relevant provisions of the GA/CA in an easy to understand language. It will also explain the tools set up to facilitate collaborative work across the Consortium.

Operational plans for National Observatories

Operational plans containing description of main actions required for the deployment and functioning of the four National Observatories.

Material for education and clinical implementation

This will include educational material and recommendations for patient recruitment and physician engagement.

Observatory business architecture

The initial design of the national and above country Observatory network, repositories and information flows, legal and ethical governance principles.

H2O Exploitation and sustainability strategy

Exploitation and sustainability strategy

First annual report on the progress and success of Observatories

Annual report of the first year of operation of the Observatories. This will include report on methodology to assess the reliability of H2O outcomes by assessing data quality and the data processing by H2O systems.

Report on requirements specifications

Report including specification for digital technology selection, adaptation and/or development produced in collaboration with Workstreams 2, 3 and 5.

Overarching operational plan for National Observatories

Operational plan containing general description of main actions required for the deployment and functioning of the National Observatories.

Report of requirements specification

Definition of requirements specification for inclusion of PROMs in the outcome set and report on the specification for digital technology selection, adaptation and/or development produced in collaboration with Workstreams 2, 3 and 4.

First version of the development platform finalised and operational

Initial versions of the development platforms will vary between countries and can contain a comprehensive interface to patients for entering PRO data, patient consent, interfaces to selected wearable devices, as well as a physician/healthcare provider portal, supporting Clinical Decision Making. Features will be added during the project time, aiming for a flexible PRO system to support further use. WP2, in collaboration with the country teams/NOs will be accountable for this.

Project communication plan and initial tool set

Plan for communicating the project progress and its results. It will comprise dissemination objectives, target audience, tools and planned activities.

Other (1)

Leaflets explaining PROs in lay terms 

Training material for PAB members to enable their informed participation in decisions on indicator selection and interpreting outcome findings.

Open Research Data Pilot (1)

Publication on the blueprint of the national and the pan-European H2O Observatories

Scientific paper

Pubblicazioni

Other (3)

Blueprint of the national and the pan-European H2O Observatories

Autori: Preston Long, Margaret R Andrews, Rob Thwaites, Nataliya Kemenyash, Tanja Stamm
Pubblicato in: 2024
Editore: Zenodo
DOI: 10.5281/zenodo.15173161

D7.4 Blueprint of the national and the pan-European H2O Observatories

Autori: Long, Preston; Andrews, Margaret R; Thwaites, Rob; Stamm, Tanja; H2O Consortium
Pubblicato in: Zenodo, 2023
Editore: CERN
DOI: 10.5281/zenodo.8167404

A PROSPECTIVE, MULTI-COUNTRY, MULTI-CENTRE, MULTI-CONDITION FEASIBILITY STUDY EVALUATING THE ESTABLISHMENT OF THE NATIONAL HEALTH OUTCOMES OBSERVATORY (H2O) ECOSYSTEM

Autori: Preston Long, Valentin Ritschl, Nataliya Kemenyash, Erika Mosor, Margaret Renn Andrews, Anouk Huberts, Georg Duftschmid, Gemma Galán-Martinez, Yolima Cossio Gil, Belle de Rooij, Maria-Christine Mautner, Alexandre Chakhunashvili, Alexandra Kauttzky-Willer, Nick Carney,Liselotte Fierens, Ann-Kristin Porth, Gottfried Novacek, Nathalie Gerold, Flavia Loreto, Francesco Patalano, Meni Styliadou, Tanja
Pubblicato in: 2024
Editore: Zenodo
DOI: 10.5281/zenodo.12624969

Peer reviewed articles (9)

A Core Outcome Set for Inflammatory Bowel Diseases: Development and Recommendations for Implementation in Clinical Practice Through an International Multi-stakeholder Consensus Process

Autori: Liselotte Fierens, Nicholas Carney, Gottfried Novacek, C Janneke van der Woude, Britta Siegmund, Francesc Casellas, Natalia Borruel, Anouk S Huberts, Elena Sonnenberg, Nathalie Gerold, Christian Primas, Charlotte R H Hedin, Tanja Stamm, Mette Julsgaard, Gionata Fiorino, Simona Radice, Michela Luciana Luisa Zini, Evelyn Gross, Cornelia Sander, Ingrid Arijs, Vasiliki-Rafaela Vakouftsi, Tunde Koltai,
Pubblicato in: Journal of Crohn's and Colitis, Numero Volume 18, Numero 10, October 2024, 2023, Pagina/e Pages 1583–1595, ISSN 1873-9946
Editore: Elsevier Science
DOI: 10.1093/ecco-jcc/jjad195

Update and European consensus on a patient-centered core outcome set for multiple myeloma in clinical practice and research

Autori: Simone Oerlemans, Belle H. De Rooij, Christine Bennink, Lars Bullinger, Annemiek Broijl, Mattia D’Agostino, Edward Laane, Maria Teresa Lupo-Stanghellini, Aurore Perrot, Ruth Wester, Viorica Cursaru, Hans Scheurer, Jan Vesseur, Mehul Dalal, Rohini Sen, Tanja Stamm, Heinz Ludwig, Pieter Sonneveld
Pubblicato in: Haematologica, Numero vol. 109, no. 6, Feb. 2024, 2024, Pagina/e pp. 1956–59, ISSN 0390-6078
Editore: Ferrata Storti Foundation
DOI: 10.3324/haematol.2023.284282

Monitoring what matters to people with diabetes: Do we underestimate the importance of behaviour, attitude, and well-being?

Autori: Ann-Kristin Porth, Yuki Seidler, Preston Alexander Long, Anouk Sjoukje Huberts, Kathryn Hamilton, Tanja Stamm, Alexandra Kautzky-Willer
Pubblicato in: Patient Education and Counseling, Numero 128, 2024, Pagina/e 108377, ISSN 0738-3991
Editore: Elsevier BV
DOI: 10.1016/j.pec.2024.108377

Development of an updated, standardized, patient-centered outcome set for lung cancer

Autori: Belle H. de Rooij, Corina van den Hurk, Veerle Smaardijk, Paz Fernandez-Ortega, Arturo Navarro-Martin, Lidia Barberio, Matthias Guckenberger, Severin Schmid, Iris Walraven, Susan Vallow, Christina Kotsi, Matthias Preusser, Erika Mosor, Jente M. Klok, Annemarie Becker, Alessandra Milani, Lyudmil Ninov, Lonneke V. van de Poll-Franse
Pubblicato in: Lung Cancer, Numero Vol 173, 2022, Pagina/e 5-13, ISSN 0169-5002
Editore: Elsevier BV
DOI: 10.1016/j.lungcan.2022.08.021

Which diabetes specific patient reported outcomes should be measured in routine care? A systematic review to inform a core outcome set for adults with Type 1 and 2 diabetes mellitus: The European Health Outcomes Observatory (H2O) programme

Autori: Kathryn Hamilton, Rita Forde, Mette Due-Christensen, Katarina Eeg-Olofson, David Nathanson, Sophia Rossner, Sara Vikstrom-Greve, Ann-Kristin Porth, Yuki Seidler, Alexandra Kautzky-Willer, Laure Delbecque, Asli Zeynep Ozdemir Saltik, Yvonne Hasler, Vanesa Flores, Tanja Stamm, David Hopkins, Angus Forbes
Pubblicato in: Patient Education and Counseling, Numero Vol 116, 2023, Pagina/e 107933, ISSN 0738-3991
Editore: Elsevier BV
DOI: 10.1016/j.pec.2023.107933

Putting person-centred psychosocial diabetes care into practice: two psychosocial care pathways based on outcome preferences of people with diabetes and healthcare professionals

Autori: Ann-Kristin Porth, Yuki Seidler, Preston Alexander Long, Tanja Stamm, Anouk S Huberts, Kathryn Hamilton, Alexandra Kautzky-Willer
Pubblicato in: BMJ Mental Health, Numero 27, 2025, Pagina/e e301061, ISSN 2755-9734
Editore: BMJ Group
DOI: 10.1136/bmjment-2024-301061

Building a Value-Based Care Infrastructure in Europe: The Health Outcomes Observatory

Autori: Tanja Stamm, Nick Bott, Rob Thwaites, Erika Mosor, Margaret R. Andrews, Joris Borgdorff, Yolima Cossio-Gil, Simona de Portu, Marc Ferrante, Felix Fischer, Farhan Hameed, Jan Hazelzet, David Hopkins, Dipak Kalra, Thomas Metcalfe, Eva Molero, Rachel Newson, Francesco Patalano, Fabian Prasser, Matthias Rose, Mikkel Lindskov Sachs, Jeannette Soderberg, Valentina Strammiello, Lonneke van de Poll & Meni
Pubblicato in: NEJM Catalyst Innovations in Care Delivery, Numero Volume 2 Numero 3, 2021, Pagina/e Online, ISSN 2642-0007
Editore: NEJM Group
DOI: 10.1056/cat.21.0146

International development of a patient-centered core outcome set for assessing health-related quality of life in metastatic breast cancer patients

Autori: K. M. de Ligt, B. H. de Rooij, E. Hedayati, M. M. Karsten, V. R. Smaardijk, M. Velting, C. Saunders, L. Travado, F. Cardoso, E. Lopez, N. Carney, Y. Wengström, A. Ives, G. Velikova, M. D. L. Sousa Fialho, Y. Seidler, T. A. Stamm, L. B. Koppert, L. V. van de Poll-Franse on behalf of the Innovative Medicines Initiative - Health Outcomes Observatory (H2O) consortium
Pubblicato in: Breast Cancer Research and Treatment, Numero 198, 2023, Pagina/e 265–281, ISSN 0167-6806
Editore: Kluwer Academic Publishers
DOI: 10.1007/s10549-022-06827-6

Standardising personalised diabetes care across European health settings: A person-centred outcome set agreed in a multinational Delphi study

Autori: Ann-Kristin Porth, Anouk Sjoukje Huberts, Alizé Rogge, Angèle Helene Marie Bénard, Angus Forbes, Anja Strootker, Carmen Hurtado Del Pozo, Dagmar Kownatka, David Hopkins, David Nathanson, Henk-Jan Aanstoot, Jeanette Soderberg, Katarina Eeg-Olofsson, Kathryn Hamilton, Laure Delbecque, Lyudmil Ninov, Mette Due-Christensen, Michael Leutner, Rafael Simó, Sara Vikstrom-Greve, Sop
Pubblicato in: Diabetic Medicine, Numero 00, 2023, Pagina/e e15259, ISSN 0742-3071
Editore: Blackwell Publishing Inc.
DOI: 10.1111/dme.15259