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Biomarkers for Traumatic Brain Injury: Data Standards and Statistical Considerations
- Huie, J Russell;
- Mondello, Stefania;
- Lindsell, Christopher J;
- Antiga, Luca;
- Yuh, Esther L;
- Zanier, Elisa R;
- Masson, Serge;
- Rosario, Bedda L;
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- Ellenbogen, Richard;
- Feeser, V Ramana;
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- Temkin, Nancy;
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- Andreassen, Lasse;
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- Antun, Azasevac;
- Antoni, Anna;
- Ardon, Hilko;
- Auslands, Kaspars;
- Azouvi, Philippe;
- Luisa Azzolini, Maria;
- Baciu, Camelia;
- Badenes, Rafael;
- Bartels, Ronald;
- Barzó, Pál;
- Bauerfeind, Ursula;
- Beauvais, Romuald;
- Beer, Ronny;
- Belda, Francisco Javier;
- Bellander, Bo Michael;
- Belli, Antonio;
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- Benali, Habib;
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- Beynon, Christopher;
- Bilotta, Federico;
- Binder, Harald;
- Biqiri, Erta;
- Blaabjerg, Morten;
- Boogert, Hugo den;
- Bragge, Peter;
- Brazinova, Alexandra;
- Brinck, Vibeke;
- Brooker, Joanne;
- Brorsson, Camilla;
- Buki, Andras;
- Bullinger, Monika;
- Cabeleira, Manuel;
- Calappi, Emiliana;
- Calvi, Maria Rosa;
- Cameron, Peter;
- Carbayo, Lozano Guillermo;
- Carbonara, Marco;
- Carise, Elsa;
- Carpenter, K;
- Castaño León, Ana M;
- Causin, Francesco;
- Chevallard, Giorgio;
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- Coles, Jonathan;
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- Collett, Johnny;
- Cooper, Jamie D;
- Correia, Marta;
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- Czeiter, Endre;
- Czosnyka, Marek;
- Fizelier, Claire Dahyot;
- Damas, François;
- Damas, Pierre;
- Dawes, Helen;
- De Keyser, Véronique;
- Corte, Francesco Della;
- Depreitere, Bart;
- de Ruiter, Godard CW;
- Dilvesi, Dula;
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- Dippel, Diederik;
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- Ezer, Erzsébet;
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- Frisvold, Shirin;
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- Gagliardo, Pablo;
- Galanaud, Damien;
- Gantner, Dashiell;
- Gao, Guoyi;
- Geleijns, Karin;
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- Ghuysen, Alexandre;
- Giga, Lelde;
- Giraud, Benoit;
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- Jacobs, Bram;
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- Helseth, Eirik;
- Hertle, Daniel;
- Hoedemaekers, Astrid;
- Hoefer, Stefan;
- Horton, Lindsay;
- Huijben, Jilske;
- Hutchinson, Peter J;
- Jankowski, Stefan;
- Jarrett, Mike;
- Jelaca, Bojan;
- Jiang, Ji yao;
- Jones, Kelly;
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- Lingsma, Hester;
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- Mulazzi, Davide;
- Mühlan, Holger;
- Muraleedharan, Visakh;
- Murray, Lynnette;
- Nair, Nandesh;
- Negru, Ancuta;
- Nelson, David;
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- Polinder, Suzanne;
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- Roise, Olav;
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- Rosand, Jonathan;
- Rosenfeld, Jeffrey;
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- Rueckert, Daniel;
- Rusnák, Martin;
- Sacchi, Marco;
- Sahakian, Barbara;
- Sahuquillo, Juan;
- Sakowitz, Oliver;
- Sala, Francesca;
- Porras, Renan Sanchez;
- Sandor, Janos;
- Santos, Edgar;
- Sasu, Luminita;
- Savo, Davide;
- Schäffer, Nadine;
- Schipper, Inger;
- Schlößer, Barbara;
- Schmidt, Silke;
- Schoechl, Herbert;
- Schoonman, Guus;
- Schou, Rico Frederik;
- Schwendenwein, Elisabeth;
- Schöll, Michael;
- Sewalt, Charlie;
- Sir, Özcan;
- Skandsen, Toril;
- Smakman, Lidwien;
- Smeets, Dirk;
- Smielewski, Peter;
- Sorinola, Abayomi;
- Stamatakis, Emmanuel;
- Stanworth, Simon;
- Steinbüchel, Nicole;
- Stevanovic, Ana;
- Stevens, Robert;
- Stewart, William;
- Steyerberg, Ewout W;
- Stocchetti, Nino;
- Sundström, Nina;
- Synnot, Anneliese;
- Taccone, Fabio Silvio;
- Takala, Riikka;
- Tamás, Viktória;
- Tanskanen, Päivi;
- Taylor, Mark Steven;
- Te Ao, Braden;
- Tenovuo, Olli;
- Telgmann, Ralph;
- Teodorani, Guido;
- Theadom, Alice;
- Thomas, Matt;
- Tibboel, Dick;
- Tolias, Christos;
- Tshibanda, Jean Flory Luaba;
- Trapani, Tony;
- Tudora, Cristina Maria;
- Vajkoczy, Peter;
- Vallance, Shirley;
- Valeinis, Egils;
- der Steen, Gregory Van;
- der Jagt, Mathieu van;
- de Naalt, JV;
- van Dijck, Jeroen TJM;
- van Essen, Thomas A;
- Hecke, Wim Van;
- Heugten, Caroline van;
- Praag, Dominique Van;
- Vyvere, Thijs Vande;
- Waesberghe, Julia Van;
- Vanhaudenhuyse, Audrey;
- Vargiolu, Alessia;
- Vega, Emmanuel;
- Velt, Kimberley;
- Verheyden, Jan;
- Vespa, Paul M;
- Vik, Anne;
- Vilcinis, Rimantas;
- Vizzino, Giacinta;
- Lankamp, Carmen Vleggeert;
- Volovici, Victor;
- Voormolen, Daphne;
- Vulekovic, Peter;
- Vámos, Zoltán;
- Wade, Derick;
- Wang, Kevin KW;
- Wang, Lei;
- Wessels, Lars;
- Wiegers, Eveline;
- Wildschut, Eno;
- Williams, Guy;
- Wilson, Lindsay;
- Winkler, Maren KL;
- Wolf, Stefan;
- Ylén, Peter;
- Younsi, Alexander;
- Zaaroor, Menashe;
- Zeiler, Frederik;
- Zhihui, Yang;
- Ziverte, Agate;
- Zumbo, Fabrizio
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Published Web Location
https://doi.org/10.1089/neu.2019.6762Abstract
Recent biomarker innovations hold potential for transforming diagnosis, prognostic modeling, and precision therapeutic targeting of traumatic brain injury (TBI). However, many biomarkers, including brain imaging, genomics, and proteomics, involve vast quantities of high-throughput and high-content data. Management, curation, analysis, and evidence synthesis of these data are not trivial tasks. In this review, we discuss data management concepts and statistical and data sharing strategies when dealing with biomarker data in the context of TBI research. We propose that application of biomarkers involves three distinct steps-discovery, evaluation, and evidence synthesis. First, complex/big data has to be reduced to useful data elements at the stage of biomarker discovery. Second, inferential statistical approaches must be applied to these biomarker data elements for assessment of biomarker clinical utility and validity. Last, synthesis of relevant research is required to support practice guidelines and enable health decisions informed by the highest quality, up-to-date evidence available. We focus our discussion around recent experiences from the International Traumatic Brain Injury Research (InTBIR) initiative, with a specific focus on four major clinical projects (Transforming Research and Clinical Knowledge in TBI, Collaborative European NeuroTrauma Effectiveness Research in TBI, Collaborative Research on Acute Traumatic Brain Injury in Intensive Care Medicine in Europe, and Approaches and Decisions in Acute Pediatric TBI Trial), which are currently enrolling subjects in North America and Europe. We discuss common data elements, data collection efforts, data-sharing opportunities, and challenges, as well as examine the statistical techniques required to realize successful adoption and use of biomarkers in the clinic as a foundation for precision medicine in TBI.
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