Guidotti, E.
Pennucci, F.
Valleggi, A.
De Rosis, S.
Passino, C.
Article History
Received: 30 October 2021
Accepted: 26 August 2022
First Online: 10 September 2022
Declarations
:
: All the methods were in accordance with the declaration of Helsinki and relevant national, regional and institutional guidelines. The PROMs and PREMs Observatory obtained the nihil obstat from all Ethics Committees of the regional health care system of Tuscany Region, and namely:- “Comitato Etico Regione Toscana - Sezione Area Vasta Sud Est” examined the study protocol and expressed the nihil obstat on the 20/11/2017;- “Comitato Etico Regione Toscana - Sezione Area Vasta Centro” examined the study protocol on the 21/11/2017; nihil obstat obtained on the 27/11/2017;- “Comitato Etico Regione Toscana - Sezione Area Vasta Nord Ovest (CEAVNO)” examined the study protocol on the 07/12/2017; nihil obstat obtained on the 19/01/2018.- The “Comitato Etico Regionale per la Sperimentazione della Regione Toscana - Sezione Comitato Etico Pediatrico (CEP)” (the Pediatric Ethics Committee) examined the study protocol on the 28/11/2017 and took note on the 30/11/2017.The copies of all original declarations (in Italian) provided by the regional Ethics Committees are available upon request to the authors. We provide here below (Protocol number: 3079) the translations in English of the relevant parts of the ethical documents provided by the CEAVNO, which is the Ethics Committees of reference for this specific study. The ethical documents were sent to the Tuscany Region, as funder of the study, and/or to the Healthcare Management Laboratory (MeS Laboratory) of the Sant’Anna School, as the investigator.Protocol number: 3079.Comitato Etico Regione Toscana - Sezione Area Vasta Nord Ovest (CEAVNO).Object: Request of nihil obstat to the PROMs Project “Systematic survey on patient reported satisfaction, experience and outcomes in the healthcare system of the Tuscany region” (…).The Comitato Etico di Area Vasta Nord Ovest (CEAVNO) for the clinical experimentation, after examining the documentation above mentioned, expresses its nihil obstat to the PROMs project. (…).Please note that patient survey data were collected by the MeS Laboratory, on the behalf of the Tuscany Region and the healthcare organization, accordingly to the national guidelines of the Italian Data Protection Authority that do not require any signed consent for the data collection (Guidelines on Processing Personal Data to Perform Customer Satisfaction Surveys in the Health Care Sector, ExternalRef removed). Accordingly, the informed consent was not required for PROMs. Patients are accurately informed, also with a specific informative document, that they are free to participate or not in the survey and can drop out at any time. The willingness to participate is demonstrated by the act of providing their contact information.The use of data is regulated by a public agreement between the MeS Laboratory, as the investigator, and the Tuscany Region, as the funder, available online at the following links:Delibera n.247 del 15-03-2021,Accordo di collaborazione tra Regione Toscana e Scuola Superiore Sant’Anna di Pisa per attività di valutazione delle performance delle Aziende ed. Enti del SSR ed. ulteriori attività di supporto.Regione Toscana - Atti della Giunta.Decreto n.5192 del 01-04-2021,Approvazione programma annuale 2021 relativo alla attività di formazione manageriale della Scuola Superiore Sant’Anna – Laboratorio MeS.Regione Toscana - Atti Dei Dirigenti.
: Not required.
: None declared.