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STUDY PROTOCOL article
Front. Neurol.
Sec. Neurorehabilitation
Volume 16 - 2025 |
doi: 10.3389/fneur.2025.1527533
A Prospective Multicenter Study on Prognostic Factors and Quality of Care in Severe Acquired Brain Injury Rehabilitation Units: a project from the Tiresia Network
Provisionally accepted- 1 Mario Negri Institute for Pharmacological Research (IRCCS), Milano, Italy
- 2 ospedale riabilitativo villa rosa, APSS Trento, Pergine Valsugana, Italy
- 3 AULSS3, Venezia, Italy
- 4 AULSS8 Berica, Vicenza, Italy
- 5 Centro Cardinal Ferrari, Fontanellato, Italy
- 6 IRCCS Don Carlo Gnocchi Firenze, Florence, Tuscany, Italy
- 7 azienda-ospedaliero universitaria, Ferrara, Italy
- 8 S. Sebastiano Hospital in Correggio, IRCCS Local Health Authority of Reggio Emilia, Correggio, Italy
- 9 Ricerca in Advanced NeuroRehabilitation, Istituto S. Anna, Crotone, Italy
- 10 Azienda USL Toscana Sud Est, Arezzo, Tuscany, Italy
- 11 Clinica di Riabilitazione Toscana Spa, Arezzo, Italy
- 12 ASL Oristano, Oristano, Italy
- 13 Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Lombardy, Italy
- 14 Fondazione Don Carlo Gnocchi Onlus (IRCCS), Milan, Lombardy, Italy
- 15 UnitĂ di Neurologia, Azienda Usl Toscana Nord Ovest, Lucca, Italy
- 16 Sacro Cuore Don Calabria Hospital (IRCCS), Negrar, Italy
- 17 Montecatone Rehabilitation Institute, Imola, Italy
Background: Severe Acquired Brain Injury (sABI) presents significant challenges in clinical management and rehabilitation due to its diverse and complex nature. The primary objective of the Tiresia project is to identify medium and medium-to-long-term prognostic factors for patients with sABI and to develop outcome indicators to evaluate the quality of care in rehabilitation units.Methods: This paper outlines the protocol for a prospective observational multicenter study conducted within the Tiresia Network. The study relies on a comprehensive data collection with stringent quality control measures. Ethical considerations emphasize patient privacy protection and adherence to regulatory standards. All of the Italian intensive rehabilitation units dedicated to sABI patients were eligible to participate in the study. Twenty-seven of them joined the project and started the data collection.Discussion: The present study represents a comprehensive effort to address critical gaps in sABI research and practice through a multicenter, prospective study design. Through rigorous data collection, analysis, and ethical oversight, the Tiresia project endorses the commitment of the research community to advancing evidence-based care and optimizing patient outcomes in sABI rehabilitation.Trial registration: The study was registered on ClinicalTrials.gov (ID: NCT04905264), on 24 May 2021.
Keywords: Severe acquired brain injury, Rehabilitation, prognostic factors, quality of care, Multicenter study, Tiresia Network
Received: 13 Nov 2024; Accepted: 04 Feb 2025.
Copyright: © 2025 Nattino, Acler, Bargellesi, Bertagnoni, Carrara, De Tanti, Estraneo, Ghilardi, Lavezzi, Lombardi, Lucca, Mancuso, Montis, Mulè, Navarro, Posteraro, Rossato, Simoncini and Bertolini. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Giulia Irene Ghilardi, Mario Negri Institute for Pharmacological Research (IRCCS), Milano, Italy
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