COMED: Pushing the boundaries of cost and outcome analysis of medical technologies
COMED aimed at advancing scientific knowledge on medical devices by overcoming existing gaps associated with the evaluation of digital technologies, addressing challenges in the use of real-world data, and uncovering drivers of variation in access to medical devices across countries.
Grant agreement ID: nr. 779306
Principal investigator: Aleksandra Torbica (CeRGAS)
Team UB/Cergas: Oriana Ciani, Maria Cucciniello, Francesco Petracca, Rosanna Tarricone (CeRGAS)
Partners: Erasmus University Rotterdam (EUR), Hamburg Center for Health Economics (HCHE), University of Exeter Medical School (UEMS)
Sponsor: European Union's Horizon 2020 research and innovation program
Duration: 2018-2021
Abstract:
Digital health technologies (DHTs) have shown great promise in transforming health care, and they are expected to contribute to better patient-centered health care systems. However, assessing their added value to healthcare systems poses a number of challenges of methodological and technical nature. Comprehensive and harmonized evaluation frameworks for a common evaluation of DHTs are lacking. The COMED project aimed to fill this gap by developing recommendations for the assessment of digital health apps.
In reaching this objective, several different research activities were performed:
the analysis of the distinguishing features of digital health apps that should be considered in any assessment framework that aims to be comprehensive
a systematic review of randomized studies on digital health apps for the management of high prevalence diseases (diabetes, cardiovascular diseases, chronic respiratory diseases and cancer) which reinforced the need for more robust development and appropriate study design to sustain evidence generation
the overview of current regulatory and assessment frameworks for digital technologies, which led to the identification of 10 recommendations that should inspire assessment frameworks based on a life-cycle evidence generation approach for digital health apps. The recommendations were developed based on a literature review and subsequent validation with key stakeholders
Material produced and publications:
Tarricone R, Petracca F, Ciani O, Cucciniello M. Distinguishing features in the assessment of mHealth apps. Expert Rev Pharmacoecon Outcomes Res. 2021;21(4):521-526. doi:10.1080/14737167.2021.1891883
Cucciniello M, Petracca F, Ciani O, Tarricone R. Development features and study characteristics of mobile health apps in the management of chronic conditions: a systematic review of randomised trials. NPJ Digit Med. 2021;4(1):144. Published 2021 Oct 5. doi:10.1038/s41746-021-00517-1
Tarricone R, Petracca F, Cucciniello M, Ciani O. Recommendations for developing a lifecycle, multidimensional assessment framework for mobile medical apps. Health Econ. 2022;31 Suppl 1(Suppl 1):73-97. doi:10.1002/hec.4505
Policy recommendations for the evaluation of mHealth technologies
Presentations:
Pushing the Boundaries of Existing Methods for Cost and Outcome Analysis of Medical Technologies: First Results from H2020 EU Project COMED (A. Torbica, C. Federici, F. Petracca, B. Pongiglione), XIX National AIES Conference, Università di Pisa, October 3-4, 2019