ABSTRACT
INTRODUCTION: Data linkage systems have proven to be a powerful tool in support of combating and managing the COVID-19 pandemic. However, the interoperability and the reuse of different data sources may pose a number of technical, administrative and data security challenges. METHODS AND ANALYSIS: This protocol aims to provide a case study for linking highly sensitive individual-level information. We describe the data linkages between health surveillance records and administrative data sources necessary to investigate social health inequalities and the long-term health impact of COVID-19 in Belgium. Data at the national institute for public health, Statistics Belgium and InterMutualistic Agency are used to develop a representative case-cohort study of 1.2 million randomly selected Belgians and 4.5 million Belgians with a confirmed COVID-19 diagnosis (PCR or antigen test), of which 108 211 are COVID-19 hospitalised patients (PCR or antigen test). Yearly updates are scheduled over a period of 4 years. The data set covers inpandemic and postpandemic health information between July 2020 and January 2026, as well as sociodemographic characteristics, socioeconomic indicators, healthcare use and related costs. Two main research questions will be addressed. First, can we identify socioeconomic and sociodemographic risk factors in COVID-19 testing, infection, hospitalisations and mortality? Second, what is the medium-term and long-term health impact of COVID-19 infections and hospitalisations? More specific objectives are (2a) To compare healthcare expenditure during and after a COVID-19 infection or hospitalisation; (2b) To investigate long-term health complications or premature mortality after a COVID-19 infection or hospitalisation; and (2c) To validate the administrative COVID-19 reimbursement nomenclature. The analysis plan includes the calculation of absolute and relative risks using survival analysis methods. ETHICS AND DISSEMINATION: This study involves human participants and was approved by Ghent University hospital ethics committee: reference B.U.N. 1432020000371 and the Belgian Information Security Committee: reference Beraadslaging nr. 22/014 van 11 January 2022, available via https://www.ehealth.fgov.be/ehealthplatform/file/view/AX54CWc4Fbc33iE1rY5a?filename=22-014-n034-HELICON-project.pdf. Dissemination activities include peer-reviewed publications, a webinar series and a project website.The pseudonymised data are derived from administrative and health sources. Acquiring informed consent would require extra information on the subjects. The research team is prohibited from gaining additional knowledge on the study subjects by the Belgian Information Security Committee's interpretation of the Belgian privacy framework.