Marcellusi, Andrea
Simonelli, Claudia
Mennini, Francesco S.
Kondili, Loreta A.
,
Funding for this research was provided by:
Italian Ministry of Health (RF-2016–02364053)
Article History
Accepted: 19 July 2021
First Online: 12 October 2021
Declarations
:
: This study was funded by Italian Ministry of Health, Grant number RF-2016–02364053.
: AM, CS, FSM and LAK have no conflicts of interest to declare regarding the content of this article.
: The PITER cohort study protocol was approved by the Ethical Committee of <i>Istituto Superiore di Sanità</i> and by the local ethics committees of each clinical centre. Patient data were evaluated via an anonymous analysis, adopting codes generated by the electronic case-report form. Informed consent was obtained from each patient participating in this study.
: Cost data were collected in the real life PITER cohort. The distribution of liver fibrosis in patients that will be diagnosed by treatment was based also in a modelling study [CitationRef removed] in which real life data of the PITER cohort were used. PITER is a multicentric prospective study that was approved by the Ethical Committee of <i>Istituto Superiore di Sanità</i> (Italian National Institute of Public Health) and the local ethical committees of each of clinical centres involved in the study. By protocol, the data are the property of the participating clinical centres, while <i>Istituto Superiore di Sanità</i> acts as coordinating centre for data management and analysis. Cumulative data are reported within the paper, whereas each patient’s data are not fully available and without restrictions for ethical reasons. The datasets generated and analysed during the current study could be available upon request to all interested researchers.
: The model was shared for the peer review process. Authors can give more details upon request.
: AM, FSM, LAK and CS designed the study. AM built the modelling and validated it. CS prepared the material, managed and analyzed the real-life cost of disease management, conducted the analysis and finalised the draft of the manuscript. AM, LAK and FSM provided guidance on the methodology, reviewed the results and critically assessed the manuscript. All of the authors reviewed the results of the final draft of the manuscript and approved the final version of the manuscript. LAK had full access to all the data used in the study and had final responsibility for the decision to submit for publication.