Case Study

CENTER-TBI + QuesGen

Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury—built for multinational scale, deeply structured data, and analysis-ready outputs.

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Overview

CENTER-TBI is a European prospective longitudinal observational study aimed at improving care and outcomes for patients with traumatic brain injury. The initiative includes a multi-center “Core” study with granular clinical data collection across all severities of TBI, along with a Registry that captures basic administrative data.

Project goals
Improve characterization and classification of TBI using multi-modal approaches and emerging technologies, and identify the most effective clinical care through Comparative Effectiveness Research (CER).
From CENTER-TBI leadership
“While many data-collection options were available, we opted for QuesGen because of their in-depth experience with TBI studies…”
— Dr. Andrew Maas, Emeritus Professor of Neurosurgery, Antwerp University Hospital
At a glance
Participants
4,500+ enrolled (Core)
Registry
23,000+ patients
Centers / countries
80+ centers in 25 countries
Partnership
7 years
Data complexity
2,500+ concepts (discrete + longitudinal)
QuesGen role included study & data strategy, data curation, eCRF, data analysis, and data systems/storage.

Study setup challenges

CENTER-TBI required a user-friendly, intuitive eCRF and a dedicated extraction tool to support analyses. Patients were stratified by care pathway (ER, Admission, ICU), and skip-logic design was stratum-specific—creating substantial integration complexity in a single eCRF.

  • Stratum-specific workflows across ER, ward admission, and ICU pathways
  • Highly granular time-series data (regular + irregular sampling)
  • Stratum-specific skip logic across a unified eCRF
  • Analysis-ready transformations (wide-to-long time series)
What QuesGen built
eCRF validation
Range checks + completion status logging to flag missing elements.
Embedded SOP guidance
Data element descriptions in the eCRF to reduce site ambiguity.
Secure dual-database design
Raw secure store + clean curated store with documented pipelines.
De-identification
Dates zeroed and site identifiers anonymized; free text checked.
“This complex study model required partnering with a company that could provide a data collection system with a dedicated study-specific e-CRF with stratum-specific workflows…”
— David Menon, MD, PhD, Professor of Anaesthesia, University of Cambridge

Data curation and data quality at multinational scale

CENTER-TBI’s curation effort was larger than anticipated and required a multidisciplinary Data Curation Task Force (DCTF). The team examined missingness, plausibility, and multivariate consistency—tracking issues and resolutions via a formal ticketing system.

Rigorous cross-checking
Curation checked not only completeness and plausibility but multivariate consistency across related concepts.
Issue tracking
A formal ticketing system logged data issues and their resolution across a large, international team.
Three-part quality response
Transform/unify data with documented pipelines, work with sites to correct systematic issues, and update rules then re-flag subjects for correction.
Lesson learned
Data curation required nearly one year of work by 18 DCTF members and resulted in a high-quality dataset linked to imaging, biomarker, and genetic repositories.

Results

The study concluded in April 2020, yielding a high-quality dataset of immense size linked to imaging, biomarker, and genetic repositories. The first comprehensive CENTER-TBI results were published in The Lancet Neurology, with additional publications expected as analysis continues.

Outcome highlights
  • High-quality curated dataset across multinational sites
  • Analysis-ready transformations and documented pipelines
  • De-identified clean database aligned to governance requirements
  • Linked clinical data + imaging/biomarker/genetic repositories
“QuesGen personnel contributed substantially to the curation process… invaluable to the CENTER-TBI team and the overall study.”
— Dr. Andrew Maas
Study leadership
Andrew Maas, MD, PhD
Emeritus Professor of Neurosurgery, Antwerp University Hospital
David Menon, MD, PhD
Professor of Anaesthesia, University of Cambridge
Study footprint includes 80+ hospitals across Europe, China, India, and Australia.

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Whether you’re running a multi-site study, building a population health program, or enabling person-centered care, QuesGen delivers planning, tracking, and outcomes measurement on one coherent platform.

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