The DIANA study is an international, multicenter, prospective, observational cohort study led by Jan De Waele (MD, Ph.D.) and Liesbet DeBus (MD) at the University Hospital Ghent in Belgium. The study, endorsed by the ESICM (European Society of Intensive Care Medicine), is investigating the effects of antibiotics on infections in the ICU. The primary objective of the study is to better understand the use of antibiotic therapy to treat infections in the Intensive Care Unit (ICU) and describe the rate of de-escalation as well as the associated outcomes such as mortality, length of stay in the ICU, or relapses. Historically, most studies on antibiotic use were retrospective, monocenter studies.

 

However, not much is known about the reasons behind antibiotic use. The University Hospital Ghent is using Castor EDC to conduct an interhospital and intercountry collaborative study with the aim of establishing well-informed practices and guidelines around antibiotic use.

 

  • Industry

    Hospitals

  • Challenge

    436-page CRF, 204 centers, and over 1,600 participants

  • Solution

    eCRF with multicenter study support

  • Result

    Worldwide research collaboration

Challenge: 436-page CRF, 204 centers and 1,600 participants

Tasked with creating a 436-page CRF, Dr. Liesbet knew it would be time-consuming and extremely difficult to establish steps and dependencies on paper. Given that this is a multicenter study and a new center is added every few days, scalability also started to become a major challenge.

“Investigator-initiated studies have limited funding which is a major barrier for researchers,” explains Dr. De Waele. Without a cost-effective tool like Castor EDC, they would not have been able to capture such a large amount of data across all 204 centers. In addition, a paper CRF of this length would have been unmanageable to implement and scale.

4 myths about the benefits of paper based CRFs

I found it very easy to use! After watching the workshops I was able to easily create our eCRF in Castor

Liesbet De Bus (MD, PhD.c), University Hospital Ghent

Solution: eCRF to the rescue

The team has been using Castor EDC for their electronic data capture, having selected it for its user-friendliness, affordability, and scalability. Dr. Liesbet reported how copying the fields, data validations, and calculation features saved several hours when constructing their 436-page eCRF (electronic case report form), especially when it came to repeating certain questions or steps.

The investigators can monitor the data entry while maintaining an overview of the entire study. Every time a new center is added, the intuitive platform along with the extensive repository of training videos makes it super easy to onboard them to the Castor EDC system to begin data entry.

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Worldwide research collaboration is a reality

With international attention, the DIANA Study now has 204 centers contributing data to the study from around the world. So far, centers from Europe, Asia, Australia and North, Central and South America have expressed their interest in study participation. Dr. De Waele estimates multiple papers will be published once the entire dataset has been analyzed after the conclusion of the data collection.

 

 

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