Today, hepatitis C viral infection (HCV) is one of the leading causes of chronic liver disease, which increases the prevalence of liver cirrhosis [1]. An updated seroprevalence of hepatitis C antibodies (HCV Ab) in Belgium has been long overdue since the most recent data is from 1997. The goal of the PrevER-trial was to investigate the prevalence of HCV viral infection in the population visiting the emergency room along with the possibility of a relationship between HCV and age (and other risk factors). 

 

The team had been using Microsoft Excel and Access to store and analyze the research data. It didn’t take too long for Dr.Rob Bielen, the co-investigator of the study, to realize that these tools would fail to meet the data protection and study protocol requirements. The PrevER-trial needed to recruit more than 3,000 participants within a 4-month inclusion period. This case-study is an in-depth look into how the PrevER-trial team used Electronic Data Capture to accelerate their research and capture high-quality data. 

  • Industry

    Research institute

  • Challenge

    Capturing large datasets

  • Solution

    Switched from Microsoft Excel and Access to EDC

  • Result

    Electronic Data Capture accelerated their research

Challenge: Capturing large datasets

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, and a significant number of these patients 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 is needed in Belgium to identify the high-risk population to optimize risk-based screenings and treatment of those infected.

The PrevER-trial needed to recruit 3,000 individuals (ages 18-70) who have entered the emergency department at ZOL Genk within a 4-month inclusion period. After consenting, a simple questionnaire had to be completed by the participants. The collected blood samples were then tested for HCV antibodies (HCV Ab) and HCV RNA. When we spoke with Dr. Bielen, less than one month after they went live with their study, they had already surpassed the 400 patient inclusion mark but had only two researchers administering the surveys.

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Solution: Switched from Microsoft Excel and Access to EDC

Castor EDC’s simple layout and the use of calculations made it easy to perform the study in real-time, so inclusions could progress quickly. 

Dr. Bielen had started exploring Castor EDC after a research coordinator at the Limburg Department recommended it to him. Dr. Bielen was impressed with how easy it was to set up the study using Castor’s eCRF tools and to send patient surveys using Castor ePRO. With the data analysis to be completed later, Dr. Bielen was looking forward to Castor’s ability to easily export all the data into SPSS for analysis. If data capture had been conducted on paper or in Excel, such a large dataset would have taken days to prepare for analysis.

7 reasons to switch to an EDC from Excel

It’s all about saving lives, quickly

This study was particularly important to Dr. Bielen because of the potential benefit to its participants, as they can offer them a possible cure if diagnosed with the HCV viral infection. Furthermore, using the data captured, they will be able to establish patient characteristics to identify additional potential risk factors for HCV viral infection.

Acknowledgment
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 UniversityZiekenhuis 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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