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CORDIS

H2O Health Outcomes Observatory

CORDIS provides links to public deliverables and publications of HORIZON projects.

Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .

Deliverables

Repository of use cases of the Observatories (opens in new window)

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 (opens in new window)

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 (opens in new window)

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 (opens in new window)

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 (opens in new window)

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 (opens in new window)

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 (opens in new window)

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 (opens in new window)

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 (opens in new window)

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

Project KPIs and success metrics (opens in new window)

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 (opens in new window)

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

Scientific publication plan (opens in new window)

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

Data Management Plan v1 including first version of master informed consent (opens in new window)

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

Development of an architecture blueprint (opens in new window)

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 (opens in new window)

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 (opens in new window)

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 (opens in new window)

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

Material for clinical implementation (opens in new window)

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

Report on educational strategies and material (opens in new window)

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

Project Handbook (opens in new window)

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 (opens in new window)

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

Material for education and clinical implementation (opens in new window)

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

Observatory business architecture (opens in new window)

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 (opens in new window)

Exploitation and sustainability strategy

First annual report on the progress and success of Observatories (opens in new window)

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 (opens in new window)

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 (opens in new window)

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

Report of requirements specification (opens in new window)

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 (opens in new window)

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 (opens in new window)

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

Leaflets explaining PROs in lay terms  (opens in new window)

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

Publications

Blueprint of the national and the pan-European H2O Observatories (opens in new window)

Author(s): Preston Long, Margaret R Andrews, Rob Thwaites, Nataliya Kemenyash, Tanja Stamm
Published in: 2024
Publisher: Zenodo
DOI: 10.5281/zenodo.15173161

D7.4 Blueprint of the national and the pan-European H2O Observatories (opens in new window)

Author(s): Long, Preston; Andrews, Margaret R; Thwaites, Rob; Stamm, Tanja; H2O Consortium
Published in: Zenodo, 2023
Publisher: 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 (opens in new window)

Author(s): 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
Published in: 2024
Publisher: Zenodo
DOI: 10.5281/zenodo.12624969

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

Author(s): 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,
Published in: Journal of Crohn's and Colitis, Issue Volume 18, Issue 10, October 2024, 2023, Page(s) Pages 1583–1595, ISSN 1873-9946
Publisher: 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 (opens in new window)

Author(s): 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
Published in: Haematologica, Issue vol. 109, no. 6, Feb. 2024, 2024, Page(s) pp. 1956–59, ISSN 0390-6078
Publisher: 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? (opens in new window)

Author(s): Ann-Kristin Porth, Yuki Seidler, Preston Alexander Long, Anouk Sjoukje Huberts, Kathryn Hamilton, Tanja Stamm, Alexandra Kautzky-Willer
Published in: Patient Education and Counseling, Issue 128, 2024, Page(s) 108377, ISSN 0738-3991
Publisher: Elsevier BV
DOI: 10.1016/j.pec.2024.108377

Development of an updated, standardized, patient-centered outcome set for lung cancer (opens in new window)

Author(s): 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
Published in: Lung Cancer, Issue Vol 173, 2022, Page(s) 5-13, ISSN 0169-5002
Publisher: 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 (opens in new window)

Author(s): 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
Published in: Patient Education and Counseling, Issue Vol 116, 2023, Page(s) 107933, ISSN 0738-3991
Publisher: 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 (opens in new window)

Author(s): Ann-Kristin Porth, Yuki Seidler, Preston Alexander Long, Tanja Stamm, Anouk S Huberts, Kathryn Hamilton, Alexandra Kautzky-Willer
Published in: BMJ Mental Health, Issue 27, 2025, Page(s) e301061, ISSN 2755-9734
Publisher: BMJ Group
DOI: 10.1136/bmjment-2024-301061

Building a Value-Based Care Infrastructure in Europe: The Health Outcomes Observatory (opens in new window)

Author(s): 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
Published in: NEJM Catalyst Innovations in Care Delivery, Issue Volume 2 Issue 3, 2021, Page(s) Online, ISSN 2642-0007
Publisher: 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 (opens in new window)

Author(s): 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
Published in: Breast Cancer Research and Treatment, Issue 198, 2023, Page(s) 265–281, ISSN 0167-6806
Publisher: 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 (opens in new window)

Author(s): 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
Published in: Diabetic Medicine, Issue 00, 2023, Page(s) e15259, ISSN 0742-3071
Publisher: Blackwell Publishing Inc.
DOI: 10.1111/dme.15259

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