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Pushing the boundaries of Cost and Outcome analysis of Medical Technologies

Deliverables

COMED research synthesis, policy tools and final recommendations

COMED conclusions and recommendations following the Final Conference where the results of the project will be presented to and discussed with academics policy makers patients associations healthcare managers and industry representatives

Methodological recommendations for integrating existing data sources of real world evidence for medical devices

Methodological guidelines will be developed to inform data collection on the real world costs and outcome of medical devices in real world settings

Policy recommendations for the evaluation of mHealth technologies

Policy recommendations on how to assess outcomes associated with mhealth technologies and policy insights on how mhealth can actually reach its potential in terms of reducing costs of healthcare services delivery and improving patients health outcomes

Results on explaining unwarranted variation in medical practice use of medical devices including levers for reduction

Results of an analysis performed of the observed variations in medical practice empirically These will be able to show unwarranted medical practice variation and explain the underlying reasons for these variations

Project Quality Management Plan

A document that sets out the quality standards to be met during the lifetime of the project

Operationalization of the scientific model and the description of structure for data library

Operalization of a scientific model capable of identifying and explaining variations in medical practice use of medical devices within and between countries, and of the description of the structure for the data library.

Dissemination and exploitation Plan

Detailed plan for the dissemination and communication of the project results

Data Management Plan

This will be the first version and it will be updated throughout the life of the project.

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Publications

Validity of Surrogate Endpoints and Their Impact on Coverage Recommendations: A Retrospective Analysis across International Health Technology Assessment Agencies

Author(s): Oriana Ciani; Bogdan Grigore; Hedwig Blommestein; Saskia de Groot; Meilin Möllenkamp; Stefan Rabbe; Rita Daubner-Bendes; Rod S. Taylor
Published in: Medical Decision Making, Issue 4, 2021, Page(s) 439-452, ISSN 0272-989X
DOI: 10.5281/zenodo.4665387

Challenges with Coverage with Evidence Development Schemes for Medical Devices: A Systematic Review

Author(s): Vivian Reckers-Droog, Carlo Federici, Werner Brouwer, Michael Drummond
Published in: Health Policy and Technology, 2020, ISSN 2211-8837
DOI: 10.1016/j.hlpt.2020.02.006

Surrogate Endpoints in Health Technology Assessment: An International Review of Methodological Guidelines

Author(s): Bogdan Grigore, Oriana Ciani, Florian Dams, Carlo Federici, Saskia de Groot, Meilin Möllenkamp, Stefan Rabbe, Kosta Shatrov, Antal Zemplenyi, Rod S. Taylor
Published in: PharmacoEconomics, 2020, ISSN 1170-7690
DOI: 10.1007/s40273-020-00935-1

Distinguishing features in the assessment of mHealth apps

Author(s): Rosanna Tarricone, Francesco Petracca, Oriana Ciani, Maria Cucciniello
Published in: Expert Review of Pharmacoeconomics & Outcomes Research, 2021, Page(s) 1-6, ISSN 1473-7167
DOI: 10.1080/14737167.2021.1891883

Challenges with Coverage with Evidence Development Schemes for Medical Devices : A Systematic Review

Author(s): Reckers-Droog, Vivian.; Federici, Carlo.; Brouwer, Werner.; Drummond, M.F.
Published in: Health Policy and Technology, Issue 2, 2020, Page(s) 146-156, ISSN 2211-8837
DOI: 10.1016/j.hlpt.2020.02.006

Quo Vadis HTA for Medical Devices in Central and Eastern Europe? Recommendations to Address Methodological Challenges

Author(s): Rita Daubner-Bendes, Sándor Kovács, Maciej Niewada, Mirjana Huic, Michael Drummond, Oriana Ciani, Carl Rudolf Blankart, Olena Mandrik, Aleksandra Torbica, John Yfantopoulos, Guenka Petrova, Malwina Holownia-Voloskova, Rod S. Taylor, Maiwenn Al, Oresta Piniazhko, László Lorenzovici, Rosanna Tarricone, Antal Zemplényi, Zoltán Kaló
Published in: Frontiers in Public Health, Issue 8, 2021, ISSN 2296-2565
DOI: 10.3389/fpubh.2020.612410

Regulatory and HTA Early Dialogues in Medical Devices

Author(s): Carl Rudolf Blankart, Florian Dams, Hannah Penton, Zoltán Kaló, Antal Zemplényi, Kosta Shatrov, Rowan Iskandar, Carlo Baldassarre Federici
Published in: Health Policy, 2021, ISSN 0168-8510
DOI: 10.1016/j.healthpol.2021.07.010