Funding for this research was provided by:
Medical Research Council (MC_UU_00002/11, MC_UU_00002/10, MC_UU_00002/11, MC_UU_00002/11)
UK Research and Innovation (UKRI-MRC/NIHR/DHSC COVID-19 rapid response call MC_PC_19074, UKRI-MRC/NIHR/DHSC COVID-19 rapid response call MC_PC_19074)
Received: 30 April 2021
Accepted: 24 September 2021
First Online: 7 October 2021
: Data collection and analysis were part of outbreak investigations during a public health emergency. Processing of COVID-19 data is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care, and therefore exempted from institutional review board approval (Regulation EU 2016/679 GDPR). The use of the data for this retrospective cohort study was approved by the COVID-19 Research Committee of Regione Lombardia. The research question, design and data collection were motivated by the public health emergency response to the COVID-19 epidemic early in March 2020. Regione Lombardia collected data during the emergency using the existing information system for infectious diseases, regulated by a 2004 regional decree, that was then updated in May 2020 to regulate the COVID-19 data flows. Data are pseudo-anonymized. Informed consent from all subjects and legal guardians of minor patients for this data collection at patient level is given prior to the data collection in hospitals and laboratories, which send the data to Regione Lombardia. Although patients were not directly involved in the study design, the experiences of clinicians and public health officials interacting with patients were crucial to the design of the data collection.
: Not applicable.
: The authors declare no competing interests.