Largest single-site TBI study

Executive Summary

QuesGen Systems is very pleased to be working with Hennepin County Medical Center (HCMC) on the nation’s largest, single-center prospective study on Concussion and TBI. The study is being led by HCMC’s neurosurgeon Dr. Uzma Samadani to develop objective, multi-modal classification schemes and outcome measures for traumatic brain injury (TBI). These measures include (1) blood-based biomarkers, which indicate which types of cells are damaged; (2) eye tracking, which detects mass effect/elevated intracranial pressure and pathway disruption; (3) radiographic measures of CT and MRI, which detect structural abnormalities; and (4) standardized outcome measures.

“As the largest single-site TBI study, we have unique data management requirements. QuesGen tailored their platform to successfully meet our needs.”  Dr. Uzma Samadani, Assoc Prof Neurosurgery at Univ of Minn.

Challenges

Hennepin County’s first milestone was to get the database up and running and to start enrolling participants as quickly as possible. They were also very concerned with how user-friendly the platform would be for their non-data savvy clinicians, yet also be useful to their very technical hard-core data experts. Lastly, the team wanted a platform with exceptional extract functionality for analyzing the data, as well as the ability to allow them to create SQL queries.  Using the QuesGen TBI platform, the Hennepin County data management team lead by Margaret Mahan, Neurosurgery Scientist was able to get the study up and running in 6 weeks.

“The ability to use the QuesGen TBI data model and eCRFs as a starting point gave us a foundation and structure that allowed us to develop our system quickly. We enrolled our first subject within a month and a half of starting database development.” – Margaret Mahan, Neurosurgery Scientist, Hennepin County Medical Center

Working with QuesGen

Since the HCMC team includes both technical and non-technical users, they wanted a system that was easy to use while providing team members the ability to write SQL Queries for extracts.

With roughly 1,200 participants, making sure all follow-ups have been completed can be very challenging. The QuesGen TBI platform allows SQL statements for queries to determine which patients need to be followed up within the coming weeks, etc. The HCMC team can simply create a SQL statement to extract that information, which is an incredible time saver.

“Our use of QuesGen has been very positive. Set-up was intuitive, prompt, and required minimal training. The QuesGen client services team is very responsive and easy to work with. They are very good at understanding the needs of the users and executing. We feel the biggest differentiators between QuesGen and the other platforms we considered is the users’ ability to get data out immediately in different formats, front-end query capabilities, and experience interfacing with other platforms.” – Margaret Mahan, Neurosurgery Scientist, HCMC

TBI research at the Minnesota State Fair

Dr. Samadani and her team took advantage of a unique opportunity that the Minnesota State Fair presented.  In an effort to create diagnostic tools to help classify brain injury better, participants answered questions and watched videos on a computer which tracked their eye movement for 30 minutes. Dr. Samadani’s research team is working tirelessly toward better ways to access TBI and advance research in this area.

“At the Minnesota State Fair, we were able to collect data on approximately 700 people from the general population in less than two weeks. This was in large part due to the efficient and intuitive setup with QuesGen.”  – Dr. Uzma Samadani, Assoc Prof Neurosurgery at Univ of Minn.

Results

With the help of QuesGen’s TBI Data Management platform, Dr. Samadani and her team are well on their way to an incredibly successful TBI study with over 1200 participants.

“QuesGen’s platform is user-friendly while being rich in functionality, which serves our multifaceted team, from physicians to analysts to research assistants.” – Maggie Mahan, Neurosurgery Scientist, HCMC

“We’ve been fortunate to incorporate QuesGen’s experience in data management of clinical  TBI research with our studies” – Dr. Uzma Samadani, Assoc Prof Neurosurgery at Univ of Minn.