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Study Type: Observational
Study Design: Prospective interventional cohort
Initiator: Rob Bielen MD, c.PhD Hasselt University/Ziekenhuis Oost Limburg Genk
Official Title: Prevalence of Hepatitis C in the general population in Belgium: a monocentric seroprevalence study at the emergency department (PrevER-trial)

Today hepatitis C viral infection (HCV) is one of the leading causes of chronic liver disease, increasing the prevalence of liver cirrhosis [1]. An updated seroprevalence of hepatitis C antibodies (HCV Ab) in Belgium is long overdue, where the most recent data is from 1997. The PrevER-trial (Prevalence of Hepatitis C in the general population in Belgium: a monocentric seroprevalence study at the emergency department) is investigating the prevalence of HCV viral infection in the population visiting the emergency department and the possible relation between HCV and age or certain risk factors. Castor spoke with co-investigator Rob Bielen, a MD and PhD candidate in Gastro-Enterology/Hepatology in the Faculty of biomedicine and life sciences at the Hasselt University/Ziekenhuis Oost Limburg Genk (ZOL Genk) about the study.

Hepatitis is an inflammation of the liver and can be caused by drugs, alcohol and viral infections [2]. HCV can cause acute (short-lived) or chronic (lifelong) hepatitis infection. A significant number of individuals will develop liver cancer or cirrhosis [1]. Antiviral medicines are largely successful at curing the infection, however access to diagnosis and treatment is low because acute hepatitis C viral infection is asymptomatic [1]. Good epidemiological data are needed in Belgium to identify the high-risk population to optimize risk-based screenings and treatment of those infected.

The PrevER-trial is recruiting 3000 individuals who enter the emergency department at ZOL Genk within a 4-month inclusion period. Individuals aged 18-70 years are asked if they wish to participate. After consenting, a simple questionnaire is completed. The collected blood samples are then tested for HCV antibodies (HCV Ab) and HCV RNA. When we spoke with Rob, less than one month after they went “Live”, they had already surpassed the 400 patient inclusion mark with only two researchers administering the surveys.

The simple lay-out, and the use of calculators make it easy to perform the study in real-life, so inclusions can progress quickly.

Recommended by the research coordinator at the Limburg Department to use Castor EDC for their data collection, Rob said he found it easy to use and affordable. Using Microsoft Excel and Access would not meet the data protection and study protocols requirements. Rob was impressed with how easily he could set up his study, saying it was “straightforward.” With the data analysis to be done later, Rob is looking forward to the functionality in Castor that will allow him to export all the data for SPSS. If data collection had been done on paper or in Excel, such a large dataset would have taken days to prepare for analysis.

The study is particularly important to Rob because of the benefit to its participants, as they can offer the patients a possible cure if diagnosed with the HCV viral infection. With the data collected they will be able to establish patient characteristics to identify additional potential risk factors for HCV viral infection.

We look forward to seeing the publications following the conclusion of the study and we wish Rob and his team success!

Acknowledgements

This study is part of the Limburg Clinical Research Program (LCRP), supported by the Limburg Sterk Merk foundation, the Province of Limburg, the Flemish Government, Hasselt University, Ziekenhuis Oost-Limburg, and Jessa Hospital.

Sources:

1. http://www.who.int/mediacentre/factsheets/fs164/en/
2. https://www.cdc.gov/hepatitis/hcv/cfaq.htm

 

 

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