Text and Data Mining valid from 2019-12-01
Received: 26 April 2018
Accepted: 13 November 2019
First Online: 6 December 2019
Ethics approval and consent to participate
: The study was approved by the Ethics Committee of the province of Reggio Emilia. The Ethics Committee exempted the study from obtaining informed consent from the patients since the object of the study was not a new treatment. All GPs signed an informed consent to participate in the study.Trial number: NCT02691754 (Approved February 24, 2016). The Reggio Emilia public health primary care service treats the personal data of the subjects participating in the trial as an independent Data Controller, in accordance with the European legislation referred to in the GDPR 679/2016 and, as provided for, of Legislative Decree 196/2003.Primary care service is the owner of the data collected in clinical practice and for the use of personal and sensitive data of patients for research purposes. According to Italian legislation (at the time of the study the Legislative Decree 196/2003), GPs have to obtain written consent to process data and personal information from his beneficiaries in order to receive the results of prescribed tests and other selected information from eventual hospital admissions, absence of this consent is a very rare conditions and implicitly would determine the exclusion of the patient from the study, since the GP could not include these patients in the osteoarthritic lists. The consent to participate in the study is provided by GP’s, since it is the GP to be randomized.
: Not required.
: The authors declare that they have no competing interests.