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Opportunities and Challenges in High-Quality Contemporary Data Collection in Traumatic Brain Injury: The CENTER-TBI Experience

  • Big Data in Neurocritical Care
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Abstract

Strong evidence in support of guidelines for traumatic brain injury (TBI) is lacking. Large-scale observational studies may offer a complementary source of evidence to clinical trials to improve the care and outcome for patients with TBI. They are, however, challenging to execute. In this review, we aim to characterize opportunities and challenges of large-scale collaborative research in neurotrauma. We use the setup and conduct of Collaborative European Neurotrauma Effectiveness Research in TBI (CENTER-TBI) as an illustrative example. We highlight the importance of building a team and of developing a network for younger researchers, thus investing toward the future. We involved investigators early in the design phase and recognized their efforts in a group contributor list on all publications. We found, however, that translation to academic credits often failed, and we suggest that the current system of academic credits be critically appraised. We found substantial variability in consent procedures for participant enrollment within and between countries. Overall, obtaining approvals typically required 4–6 months, with outliers up to 18 months. Research costs varied considerably across Europe and should be defined by center. We substantially underestimated costs of data curation, and we suggest that 15–20% of the budget be reserved for this purpose. Streamlining analyses and accommodating external research proposals demanded a structured approach. We implemented a systematic inventory of study plans and found this effective in maintaining oversight and in promoting collaboration between research groups. Ensuring good use of the data was a prominent feature in the review of external proposals. Multiple interactions occurred with industrial partners, mainly related to biomarkers and neuroimaging, and resulted in various formal collaborations, substantially extending the scope of CENTER-TBI. Overall, CENTER-TBI has been productive, with over 250 international peer-reviewed publications. We have ensured mechanisms to maintain the infrastructure and continued analyses. We see potential for individual patient data meta-analyses in connection to other large-scale projects. Our collaboration with Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) has taught us that although standardized data collection and coding according to common data elements can facilitate such meta-analyses, further data harmonization is required for meaningful results. Both CENTER-TBI and TRACK-TBI have demonstrated the complexity of the conduct of large-scale collaborative studies that produce high-quality science and new insights.

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Acknowledgements

The authors would like to thank all participants and investigators for contributing to the team spirit of CENTER-TBI and dedicating their time and efforts to the project. We are grateful to all patients for their participation in the CENTER-TBI study.

Funding

The work of CENTER-TBI was supported by the European Commission FP7 (602150). Additional funding was obtained from Hannelore Kohl Stiftung (Germany), from OneMind (USA), from Integra LifeSciences Corporation (USA), and from Neurotrauma Sciences (USA). The funders had no role in the design of the study; collection, analysis, interpretation of data; and writing of the manuscript. All authors had full access to the study data and had final responsibility for the decision to submit for publication.

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Authors and Affiliations

  1. Department of Neurosurgery, Antwerp University Hospital and University of Antwerp, Drie Eikenstraat 655, 2650, Edegem, Belgium

    Andrew I. R. Maas & Veronique De Keyser

  2. Division of Anaesthesia, University of Cambridge and Addenbrooke’s Hospital, Box 93, Cambridge, CB2 0QQ, UK

    Ari Ercole & David K. Menon

  3. Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands

    Ewout W. Steyerberg

Authors
  1. Andrew I. R. Maas
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  2. Ari Ercole
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  3. Veronique De Keyser
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  4. David K. Menon
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  5. Ewout W. Steyerberg
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Contributions

All authors were involved in the concept, design, and execution of CENTER-TBI and have all contributed to this review. The final manuscript was approved by all authors.

Corresponding author

Correspondence to Andrew I. R. Maas.

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Conflicts of Interest

All authors were involved in the CENTER-TBI study, primarily supported by the FP7 program of the European Union. The authors report no relevant conflicts of interest.

Ethical approval/informed consent

CENTER-TBI adhered to ethical guidelines, IRB approvals were obtained in all participating centers, and consent was obtained from all participants or their proxies according to national and local regulations. The CENTER-TBI study (grant 602150) has been conducted in accordance with all relevant laws of the European Union, if directly applicable or of direct effect, and all relevant laws of the country where the recruiting sites were located, including, but not limited to, the relevant privacy and data protection laws and regulations (the “Privacy Law”), the relevant laws and regulations on the use of human materials, and all relevant guidance relating to clinical studies from time to time in force, including, but not limited to, the ICH Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) (“ICH GCP”) and the World Medical Association Declaration of Helsinki entitled “Ethical Principles for Medical Research Involving Human Subjects.” Informed consent by the patients and/or the legal representative/next of kin was obtained, according to the local legislations, for all patients recruited in the core data set of CENTER-TBI and documented in the e-CRF. Ethical approval was obtained for each recruiting site. The list of sites, ethical committees, approval numbers, and approval dates can be found on the website: https://www.center-tbi.eu/project/ethical-approval. We note, however, that the current review article did not make use of individual patient data.

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Maas, A.I.R., Ercole, A., De Keyser, V. et al. Opportunities and Challenges in High-Quality Contemporary Data Collection in Traumatic Brain Injury: The CENTER-TBI Experience. Neurocrit Care 37 (Suppl 2), 192–201 (2022). https://doi.org/10.1007/s12028-022-01471-w

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