{"id":3807,"date":"2023-12-06T14:24:28","date_gmt":"2023-12-06T13:24:28","guid":{"rendered":"https:\/\/ripi.iss.it\/ripi\/?page_id=3807"},"modified":"2023-12-06T14:36:51","modified_gmt":"2023-12-06T13:36:51","slug":"from-pilot-study-to-registry","status":"publish","type":"page","link":"https:\/\/ripi.iss.it\/ripi\/en\/related-projects\/rnpm-en\/from-pilot-study-to-registry\/","title":{"rendered":"From pilot study to registry"},"content":{"rendered":"
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The National Breast Implant Registry<\/a> was established in 2012 by Law no. 86 under the aegis of the Italian Ministry of Health<\/strong>. However, in the same year, the Decree-Law 179 dated 18 October 2012 required that the Registry had to be established by a Prime Minister Decree (DPCM), which was then published on 3 March 2017.<\/p>\n

At the beginning of 2017, a collaboration between the Italian National Institute of Health (ISS) and the Ministry of Health was established in consideration of ISS long-term expertise in the development of the Italian Arthroplasty Registry (RIAP).<\/strong> This cooperation led to the selection of the flow model for data collection, the type of information to be collected, and the implementation of a platform to launch the pilot study. The pilot phase<\/a>, that was crucial to verify the functioning of data collection system and its application at the national level, lasted from 25 March 2019 to 31 August 2021. In the meantime, the Ministry of health had been finalizing the draft Regulatory Decree required by the DPCM 3\/3\/2017.<\/p>\n

The Report of the pilot phase<\/a> illustrates the methodology followed to design the data collection system in collaboration with all stakeholders involved in a breast implant surgery (regions, autonomous provinces, scientific societies and breast implant distributors in Italy) and the results of collected data.<\/p>\n

The main milestones in the development of the National Breast Implant Registry are the following:<\/p>\n