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Study Type: Observational
Study Design: Prospective, Multicenter, Cohort
Initiator: University Hospital Ghent: Liesbet De Bus (MD, PhD.c), Jan De Waele (MD, PhD, Associate Prof.)
Official Title: DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care (DIANA Study)

The DIANA study is a multicenter, international, prospective, observational cohort study lead by Jan De Waele (MD, PhD) and Liesbet De Bus (MD) out of the University Hospital Ghent in Belgium. The study, endorsed by the ESICM (European Society of Intensive Care Medicine), is investigating the use of antibiotics. 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 ICU, or relapses. Not much is known on the reasons behind antibiotic use, and historically most studies on antibiotic use were retrospective, single center studies. However inter-hospital and inter-country attitudes are important for informing practices and guidelines, it is clear more research is needed in this area.

Liesbet De Bus presenting the eCRF at the kick-off meeting in Milan.

 

The team has been using Castor EDC for their electronic data collection, having selected it for its user friendliness, affordability and scalability. Liesbet reported how the copy and paste functions saved time when constructing the 436 page eCRF (electronic case report form), especially when it came to repeating certain questions or steps. Since the study has gone live, she can monitor data entry while maintaining an overview of the entire study. A new center is added every few days and new users are easy to onboard to the CastorEDC system to begin data entry. The team estimate 2500 participants will be enrolled in the study.

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

Investigator initiated studies have limited funding which is a major barrier for researchers explains Jan. Without Castor EDC, they would not have been able to collect such a large amount of data across all centers with the limited amount of local funding they received. And a paper CRF of this length would certainly not have been manageable.

With international attention, the goal is to have 150 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. Hospitals in Europe and Asia are currently including patients. Jan estimates multiple papers will be published once the entire dataset has been analyzed after the conclusion of the data collection at the end of December 2017.

Castor EDC is proud to support and enable investigators initiated multicenter research studies like the DIANA study. We look forward to reading the publications, for more information visit the DIANA study website here.

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