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1. Traumatic brain injury: progress and challenges in prevention, clinical care, and research

Author

Maas, Andrew I R, Menon, David K, Manley, Geoffrey T, Abrams, Mathew, Åkerlund, Cecilia, Andelic, Nada, Aries, Marcel, Bashford, Tom, Bell, Michael J, Bodien, Yelena G, Brett, Benjamin L, Büki, András, Chesnut, Randall M, Citerio, Giuseppe, Clark, David, Clasby, Betony, Cooper, D Jamie, Czeiter, Endre, Czosnyka, Marek, Dams-O'Connor, Kristen, De Keyser, Véronique, Diaz-Arrastia, Ramon, Ercole, Ari, van Essen, Thomas A, Falvey, Éanna, Ferguson, Adam R, Figaji, Anthony, Fitzgerald, Melinda, Foreman, Brandon, Gantner, Dashiell, Gao, Guoyi, Giacino, Joseph, Gravesteijn, Benjamin, Guiza, Fabian, Gupta, Deepak, Gurnell, Mark, Haagsma, Juanita A, Hammond, Flora M, Hawryluk, Gregory, Hutchinson, Peter, van der Jagt, Mathieu, Jain, Sonia, Jain, Swati, Jiang, Ji-yao, Kent, Hope, Kolias, Angelos, Kompanje, Erwin J O, Lecky, Fiona, Lingsma, Hester F, Maegele, Marc, Majdan, Marek, Markowitz, Amy, McCrea, Michael, Meyfroidt, Geert, Mikolić, Ana, Mondello, Stefania, Mukherjee, Pratik, Nelson, David, Nelson, Lindsay D, Newcombe, Virginia, Okonkwo, David, Orešič, Matej, Peul, Wilco, Pisică, Dana, Polinder, Suzanne, Ponsford, Jennie, Puybasset, Louis, Raj, Rahul, Robba, Chiara, Røe, Cecilie, Rosand, Jonathan, Schueler, Peter, Sharp, David J, Smielewski, Peter, Stein, Murray B, von Steinbüchel, Nicole, Stewart, William, Steyerberg, Ewout W, Stocchetti, Nino, Temkin, Nancy, Tenovuo, Olli, Theadom, Alice, Thomas, Ilias, Espin, Abel Torres, Turgeon, Alexis F, Unterberg, Andreas, Van Praag, Dominique, van Veen, Ernest, Verheyden, Jan, Vyvere, Thijs Vande, Wang, Kevin K W, Wiegers, Eveline J A, Williams, W Huw, Wilson, Lindsay, Wisniewski, Stephen R, Younsi, Alexander, Yue, John K, Yuh, Esther L, Zeiler, Frederick A, Zeldovich, Marina, and Zemek, Roger

Published
2022
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9. Outcomes of ICU patients with and without perceptions of excessive care: a comparison between cancer and non-cancer patients

Author

Benoit, Dominique D., van der Zee, Esther N., Darmon, Michael, Reyners, An K. L., Metaxa, Victoria, Mokart, Djamel, Wilmer, Alexander, Depuydt, Pieter, Hvarfner, Andreas, Rusinova, Katerina, Zijlstra, Jan G., Vincent, François, Lathyris, Dimitrios, Meert, Anne-Pascale, Devriendt, Jacques, Uyttersprot, Emma, Kompanje, Erwin J. O., Piers, Ruth, and Azoulay, Elie

Published
2021
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10. Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research

Author

Adams, Hadie, Agnoletti, Vanni, Allanson, Judith, Amrein, Krisztina, Andaluz, Norberto, Anke, Audny, Antoni, Anna, van As, Arjan Bastiaan, Audibert, Gérard, Azaševac, Antun, Azouvi, Philippe, Azzolini, Maria Luisa, Baciu, Camelia, Badenes, Rafael, Barlow, Karen M, Bartels, Ronald, Bauerfeind, Ursula, Beauchamp, Miriam, Beer, Darcy, Beer, Ronny, Belda, Francisco Javier, Bellander, Bo-Michael, Bellier, Rémy, Benali, Habib, Benard, Thierry, Beqiri, Valzerda, Beretta, Luigi, Bernard, Francis, Bertolini, Guido, Bilotta, Federico, Blaabjerg, Morten, den Boogert, Hugo, Boutis, Kathy, Bouzat, Pierre, Brooks, Brian, Brorsson, Camilla, Bullinger, Monika, Burns, Emma, Calappi, Emiliana, Cameron, Peter, Carise, Elsa, Castaño-León, Ana M, Causin, Francesco, Chevallard, Giorgio, Chieregato, Arturo, Christie, Brian, Cnossen, Maryse, Coles, Jonathan, Collett, Johnny, Della Corte, Francesco, Craig, William, Csato, Gabor, Csomos, Akos, Curry, Nicola, Dahyot-Fizelier, Claire, Dawes, Helen, DeMatteo, Carol, Depreitere, Bart, Dewey, Deborah, van Dijck, Jeroen, Đilvesi, Đula, Dippel, Diederik, Dizdarevic, Kemal, Donoghue, Emma, Duek, Or, Dulière, Guy-Loup, Dzeko, Adelaida, Eapen, George, Emery, Carolyn A, English, Shane, Esser, Patrick, Ezer, Erzsébet, Fabricius, Martin, Feng, Junfeng, Fergusson, Dean, Figaji, Anthony, Fleming, Joanne, Foks, Kelly, Francony, Gilles, Freedman, Stephen, Freo, Ulderico, Frisvold, Shirin K, Gagnon, Isabelle, Galanaud, Damien, Gantner, Dashiell, Giraud, Benoit, Glocker, Ben, Golubovic, Jagoš, Gómez López, Pedro A, Gordon, Wayne A, Gradisek, Primoz, Gravel, Jocelyn, Griesdale, Donald, Grossi, Francesca, Haagsma, Juanita A, Håberg, Asta Kristine, Haitsma, Iain, Van Hecke, Wim, Helbok, Raimund, Helseth, Eirik, van Heugten, Caroline, Hoedemaekers, Cornelia, Höfer, Stefan, Horton, Lindsay, Hui, Jiyuan, Huijben, Jilske Antonia, Hutchinson, Peter J, Jacobs, Bram, van der Jagt, Mathieu, Jankowski, Stefan, Janssens, Koen, Jelaca, Bojan, Jones, Kelly M, Kamnitsas, Konstantinos, Kaps, Rafael, Karan, Mladen, Katila, Ari, Kaukonen, Kirsi-Maija, De Keyser, Véronique, Kivisaari, Riku, Kolias, Angelos G, Kolumbán, Bálint, Kolundžija, Ksenija, Kondziella, Daniel, Koskinen, Lars-Owe, Kovács, Noémi, Kramer, Andreas, Kutsogiannis, Demitri, Kyprianou, Theodoros, Lagares, Alfonso, Lamontagne, François, Latini, Roberto, Lauzier, François, Lazar, Isaac, Ledig, Christian, Lefering, Rolf, Legrand, Valerie, Levi, Leon, Lightfoot, Roger, Lozano, Angels, MacDonald, Stephen, Major, Sebastian, Manara, Alex, Manhes, Pauline, Maréchal, Hugues, Martino, Costanza, Masala, Alessandro, Masson, Serge, Mattern, Julia, McFadyen, Bradford, McMahon, Catherine, Meade, Maureen, Melegh, Béla, Menovsky, Tomas, Moore, Lynne, Morgado Correia, Marta, Morganti-Kossmann, Maria Cristina, Muehlan, Holger, Mukherjee, Pratik, Murray, Lynnette, van der Naalt, Joukje, Negru, Ancuta, Nelson, David, Nieboer, Daan, Noirhomme, Quentin, Nyirádi, József, Oddo, Mauro, Okonkwo, David O, Oldenbeuving, Annemarie W, Ortolano, Fabrizio, Osmond, Martin, Payen, Jean-François, Perlbarg, Vincent, Persona, Paolo, Pichon, Nicolas, Piippo-Karjalainen, Anna, Pili-Floury, Sébastien, Pirinen, Matti, Ple, Horia, Poca, Maria Antonia, Posti, Jussi, Van Praag, Dominique, Ptito, Alain, Radoi, Andreea, Ragauskas, Arminas, Raj, Rahul, Real, Ruben G L, Reed, Nick, Rhodes, Jonathan, Robertson, Claudia, Rocka, Saulius, Røe, Cecilie, Røise, Olav, Roks, Gerwin, Rosand, Jonathan, Rosenfeld, Jeffrey V, Rosenlund, Christina, Rosenthal, Guy, Rossi, Sandra, Rueckert, Daniel, de Ruiter, Godard C W, Sacchi, Marco, Sahakian, Barbara J, Sahuquillo, Juan, Sakowitz, Oliver, Salvato, Gerardo, Sánchez-Porras, Renán, Sándor, János, Sangha, Grinder, Schäfer, Nadine, Schmidt, Silke, Schneider, Kathryn J, Schnyer, David, Schöhl, Herbert, Schoonman, Guus G, Schou, Rico Frederik, Sir, Özcan, Skandsen, Toril, Smeets, Dirk, Sorinola, Abayomi, Stamatakis, Emmanuel, Stevanovic, Ana, Stevens, Robert D, Sundström, Nina, Taccone, Fabio Silvio, Takala, Riikka, Tanskanen, Päivi, Taylor, Mark Steven, Telgmann, Ralph, Temkin, Nancy, Teodorani, Guido, Thomas, Matt, Tolias, Christos M, Trapani, Tony, Turgeon, Alexis, Vajkoczy, Peter, Valadka, Alex B, Valeinis, Egils, Vallance, Shirley, Vámos, Zoltán, Vargiolu, Alessia, Vega, Emmanuel, Verheyden, Jan, Vik, Anne, Vilcinis, Rimantas, Vleggeert-Lankamp, Carmen, Vogt, Lidia, Volovici, Victor, Voormolen, Daphne C, Vulekovic, Peter, Vande Vyvere, Thijs, Van Waesberghe, Julia, Wessels, Lars, Wildschut, Eno, Williams, Guy, Winkler, Maren K L, Wolf, Stefan, Wood, Gordon, Xirouchaki, Nektaria, Younsi, Alexander, Zaaroor, Menashe, Zelinkova, Veronika, Zemek, Roger, Zumbo, Fabrizio, Maas, Andrew I R, Menon, David K, Adelson, P David, Andelic, Nada, Bell, Michael J, Belli, Antonio, Bragge, Peter, Brazinova, Alexandra, Büki, András, Chesnut, Randall M, Citerio, Giuseppe, Coburn, Mark, Cooper, D Jamie, Crowder, A Tamara, Czeiter, Endre, Czosnyka, Marek, Diaz-Arrastia, Ramon, Dreier, Jens P, Duhaime, Ann-Christine, Ercole, Ari, van Essen, Thomas A, Feigin, Valery L, Gao, Guoyi, Giacino, Joseph, Gonzalez-Lara, Laura E, Gruen, Russell L, Gupta, Deepak, Hartings, Jed A, Hill, Sean, Jiang, Ji-yao, Ketharanathan, Naomi, Kompanje, Erwin J O, Lanyon, Linda, Laureys, Steven, Lecky, Fiona, Levin, Harvey, Lingsma, Hester F, Maegele, Marc, Majdan, Marek, Manley, Geoffrey, Marsteller, Jill, Mascia, Luciana, McFadyen, Charles, Mondello, Stefania, Newcombe, Virginia, Palotie, Aarno, Parizel, Paul M, Peul, Wilco, Piercy, James, Polinder, Suzanne, Puybasset, Louis, Rasmussen, Todd E, Rossaint, Rolf, Smielewski, Peter, Söderberg, Jeannette, Stanworth, Simon J, Stein, Murray B, von Steinbüchel, Nicole, Stewart, William, Steyerberg, Ewout W, Stocchetti, Nino, Synnot, Anneliese, Te Ao, Braden, Tenovuo, Olli, Theadom, Alice, Tibboel, Dick, Videtta, Walter, Wang, Kevin K W, Williams, W Huw, Wilson, Lindsay, and Yaffe, Kristine

Published
2017
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11. Time-limited trial of intensive care treatment: an overview of current literature

Author

Vink, Eva E., Azoulay, Elie, Caplan, Arthur, Kompanje, Erwin J. O., and Bakker, Jan

Subjects
Clinical trials, Health care industry
Abstract

In critically ill patients, it is frequently challenging to identify who will benefit from admission to the intensive care unit and life-sustaining interventions when the chances of a meaningful outcome are unclear. In addition, the acute illness not only affects the patients but also family members or surrogates who often are overwhelmed and unable to make thoughtful decisions. In these circumstances, a time-limited trial (TLT) of intensive care treatment can be helpful. A TLT is an agreement to initiate all necessary treatments or treatments with clearly delineated limitations for a certain period of time to gain a more realistic understanding of the patient's chances of a meaningful recovery or to ascertain the patient's wishes and values. In this article, we discuss current research on different aspects of TLTs in the intensive care unit. We propose how and when to use TLTs, discuss how much time should be taken for a TLT, give an overview of the potential impact of TLTs on healthcare resources, describe ethical challenges concerning TLTs, and discuss how to evaluate a TLT., Author(s): Eva E. Vink [sup.1] [sup.2], Elie Azoulay [sup.3], Arthur Caplan [sup.4], Erwin J. O. Kompanje [sup.2], Jan Bakker [sup.1] [sup.2] [sup.5] [sup.6] [sup.7] Author Affiliations: (1) 0000 0004 1936 [...]

Published
2018
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12. Comparative Effectiveness of Mannitol versus Hypertonic Saline in Traumatic Brain Injury patients: a CENTER-TBI study

Author

Veen, E, Nieboer, D, Kompanje, E, Citerio, G, Stocchetti, N, Gommers, D, Menon, D, Ercole, A, Maas, A, Lingsma, H, Jagt, M, Veen, Ernest van, Nieboer, Daan, Kompanje, Erwin J. O., Citerio, Giuseppe, Stocchetti, Nino, Gommers, Diederik A. M. P. J., Menon, David K., Ercole, Ari, Maas, Andrew I. R., Lingsma, Hester. F., Jagt, Mathieu van der, Veen, E, Nieboer, D, Kompanje, E, Citerio, G, Stocchetti, N, Gommers, D, Menon, D, Ercole, A, Maas, A, Lingsma, H, Jagt, M, Veen, Ernest van, Nieboer, Daan, Kompanje, Erwin J. O., Citerio, Giuseppe, Stocchetti, Nino, Gommers, Diederik A. M. P. J., Menon, David K., Ercole, Ari, Maas, Andrew I. R., Lingsma, Hester. F., and Jagt, Mathieu van der

Abstract

Increased intracranial pressure (ICP) is one of the most important modifiable and immediate threats to critically ill patients suffering from traumatic brain injury (TBI). Two hyperosmolar agents (HOA), mannitol and hypertonic saline (HTS) are routinely used in clinical practice to treat increased ICP. We aimed to assess whether a preference for mannitol, HTS or their combined use translated into differences in outcome. The CENTER-TBI Study is a prospective multicenter cohort study. For this study, patients with TBI, admitted to the ICU, treated with mannitol and/or HTS, aged ≥16, were included. Patients and centers were differentiated based on treatment preference with mannitol and/or HTS based on structured, data-driven criteria such as first administered HOA in the ICU. We assessed influence of center and patient characteristics in the choice of agent using adjusted multivariate models. Furthermore, we assessed the influence of HOA preference on outcome using adjusted ordinal and logistic regression models, and instrumental variable analyses. In total, 2056 patients were assessed. Of these, 502 (24%) patients received mannitol and/or HTS in the ICU. The first received HOA was HTS for 287 (57%) patients, mannitol for 149 (30%) patients, or both mannitol and HTS on the same day for 66 (13%) patients. Two unreactive pupils were more common for patients receiving both (13, 21%), compared to patients receiving HTS (40, 14%), or mannitol (22, 16%). Center, rather than patient characteristics, was independently associated with the preferred choice of HOA (p-value < 0.05). ICU mortality and 6-month outcome were similar between patients preferably treated with mannitol compared to HTS (OR = 1.0, CI = 0.4 - 2.2; OR = 0.9, CI = 0.5 - 1.6 respectively). Patients who received both also had a similar ICU mortality and 6-month outcome compared to patients receiving HTS (OR = 1.8, CI = 0.7 - 5.0; OR = 0.6, CI = 0.3 - 1.7 respectively). We found between center variability rega

Published
2023

13. A study protocol to develop and test an e‐health intervention in follow‐up service for intensive care survivors' relatives.

Author

van Mol, Margo M. C., Kompanje, Erwin J. O., van Bommel, Jasper, Latour, Jos M., Berger, E., Boeter, T., van der Veer, M., Gommers, D. A. M. P. J., van Dijk, M., Ista, E., van der Staa, A., ter Mate, A., Vloet, L., Bolman, D., and Groot, M.

Subjects
*FAMILIES & psychology, *PATIENT aftercare, *RESEARCH, *SOCIAL support, *INTENSIVE care nursing, *RESEARCH methodology, *FAMILY-centered care, *HUMAN services programs, *CRITICAL care medicine, *TELEMEDICINE
Abstract

Background: The negative impact on long‐term health‐related outcomes among relatives of critically ill patients in the intensive care unit (ICU) has been well described. High‐quality ICU specialized follow‐up care, which is easily accessible with digital innovation and which is designed by and with relevant stakeholders (i.e., ICU patients' relatives and nurses), should be considered to reduce these impairments in the psychological and social domains. Aim: The programme's aim is to develop and test an e‐health intervention in a follow‐up service to support ICU patients' relatives. Here, the protocol for the overall study programme will be described. Study Design: The overall study comprises a mixed‐methods, multicentre research design with qualitative and quantitative study parts. The study population is ICU patients' adult relatives and ICU nurses. The main outcomes are the experiences of these stakeholders with the newly developed e‐health intervention. There will be no predefined selection based on age, gender, and level of education to maximize diversity throughout the study programme. After the participants provide informed consent, data will be gathered through focus groups (n = 5) among relatives and individual interviews (n = 20) among nurses exploring the needs and priorities of a digital follow‐up service. The findings will be explored further for priority considerations among members of the patient/relative organization (aiming n = 150), which will serve as a basis for digital prototypes of the e‐health intervention. Assessment of the intervention will be followed during an iterative process with investigator‐developed questionnaires. Finally, symptoms of anxiety and depression will be measured with the 14‐item Dutch version of the 'Hospital Anxiety and Depression Scale', and symptoms of posttraumatic stress will be measured with the 21‐item Dutch version of the 'Impact of Events Scale‐Revised' to indicate the effectiveness of digital support among ICU patients' relatives. Relevance to Clinical Practice: The e‐health intervention to be developed during this research programme can possibly bridge the gap in integrated ICU follow‐up care by providing relevant information, self‐monitoring and stimulating self‐care among ICU patients' relatives. [ABSTRACT FROM AUTHOR]

Published
2023
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16. Comparative Effectiveness of Mannitol versus Hypertonic Saline in Traumatic Brain Injury patients: a CENTER-TBI study

Author

Veen, Ernest van, Nieboer, Daan, Kompanje, Erwin J. O., Citerio, Giuseppe, Stocchetti, Nino, Gommers, Diederik A. M. P. J., Menon, David K., Ercole, Ari, Maas, Andrew I. R., Lingsma, Hester. F., Jagt, Mathieu van der, Veen, E, Nieboer, D, Kompanje, E, Citerio, G, Stocchetti, N, Gommers, D, Menon, D, Ercole, A, Maas, A, Lingsma, H, and Jagt, M

Subjects
Traumatic brain injury, critical care, intensive care unit, osmolar therapy
Abstract

Increased intracranial pressure (ICP) is one of the most important modifiable and immediate threats to critically ill patients suffering from traumatic brain injury (TBI). Two hyperosmolar agents (HOA), mannitol and hypertonic saline (HTS) are routinely used in clinical practice to treat increased ICP. We aimed to assess whether a preference for mannitol, HTS or their combined use translated into differences in outcome. The CENTER-TBI Study is a prospective multicenter cohort study. For this study, patients with TBI, admitted to the ICU, treated with mannitol and/or HTS, aged ≥16, were included. Patients and centers were differentiated based on treatment preference with mannitol and/or HTS based on structured, data-driven criteria such as first administered HOA in the ICU. We assessed influence of center and patient characteristics in the choice of agent using adjusted multivariate models. Furthermore, we assessed the influence of HOA preference on outcome using adjusted ordinal and logistic regression models, and instrumental variable analyses. In total, 2056 patients were assessed. Of these, 502 (24%) patients received mannitol and/or HTS in the ICU. The first received HOA was HTS for 287 (57%) patients, mannitol for 149 (30%) patients, or both mannitol and HTS on the same day for 66 (13%) patients. Two unreactive pupils were more common for patients receiving both (13, 21%), compared to patients receiving HTS (40, 14%), or mannitol (22, 16%). Center, rather than patient characteristics, was independently associated with the preferred choice of HOA (p-value < 0.05). ICU mortality and 6-month outcome were similar between patients preferably treated with mannitol compared to HTS (OR = 1.0, CI = 0.4 - 2.2; OR = 0.9, CI = 0.5 - 1.6 respectively). Patients who received both also had a similar ICU mortality and 6-month outcome compared to patients receiving HTS (OR = 1.8, CI = 0.7 - 5.0; OR = 0.6, CI = 0.3 - 1.7 respectively). We found between center variability regarding HOA preference. Moreover, we found that center is a more important driver of the choice of HOA than patient characteristics. However, our study indicates that this variability is an acceptable practice given absence of differences in outcomes associated with a specific HOA. Traumatic brain injury, critical care, intensive care unit, osmolar therapy.

Published
2023

21. Traumatic brain injury: progress and challenges in prevention, clinical care, and research

Author

Maas, A, Menon, D, Manley, G, Abrams, M, Åkerlund, C, Andelic, N, Aries, M, Bashford, T, Bell, M, Bodien, Y, Brett, B, Büki, A, Chesnut, R, Citerio, G, Clark, D, Clasby, B, Cooper, D, Czeiter, E, Czosnyka, M, Dams-O'Connor, K, De Keyser, V, Diaz-Arrastia, R, Ercole, A, van Essen, T, Falvey, É, Ferguson, A, Figaji, A, Fitzgerald, M, Foreman, B, Gantner, D, Gao, G, Giacino, J, Gravesteijn, B, Guiza, F, Gupta, D, Gurnell, M, Haagsma, J, Hammond, F, Hawryluk, G, Hutchinson, P, van der Jagt, M, Jain, S, Jiang, J, Kent, H, Kolias, A, Kompanje, E, Lecky, F, Lingsma, H, Maegele, M, Majdan, M, Markowitz, A, Mccrea, M, Meyfroidt, G, Mikolić, A, Mondello, S, Mukherjee, P, Nelson, D, Nelson, L, Newcombe, V, Okonkwo, D, Orešič, M, Peul, W, Pisică, D, Polinder, S, Ponsford, J, Puybasset, L, Raj, R, Robba, C, Røe, C, Rosand, J, Schueler, P, Sharp, D, Smielewski, P, Stein, M, von Steinbüchel, N, Stewart, W, Steyerberg, E, Stocchetti, N, Temkin, N, Tenovuo, O, Theadom, A, Thomas, I, Espin, A, Turgeon, A, Unterberg, A, Van Praag, D, van Veen, E, Verheyden, J, Vyvere, T, Wang, K, Wiegers, E, Williams, W, Wilson, L, Wisniewski, S, Younsi, A, Yue, J, Yuh, E, Zeiler, F, Zeldovich, M, Zemek, R, Maas, Andrew I R, Menon, David K, Manley, Geoffrey T, Abrams, Mathew, Åkerlund, Cecilia, Andelic, Nada, Aries, Marcel, Bashford, Tom, Bell, Michael J, Bodien, Yelena G, Brett, Benjamin L, Büki, András, Chesnut, Randall M, Citerio, Giuseppe, Clark, David, Clasby, Betony, Cooper, D Jamie, Czeiter, Endre, Czosnyka, Marek, Dams-O'Connor, Kristen, De Keyser, Véronique, Diaz-Arrastia, Ramon, Ercole, Ari, van Essen, Thomas A, Falvey, Éanna, Ferguson, Adam R, Figaji, Anthony, Fitzgerald, Melinda, Foreman, Brandon, Gantner, Dashiell, Gao, Guoyi, Giacino, Joseph, Gravesteijn, Benjamin, Guiza, Fabian, Gupta, Deepak, Gurnell, Mark, Haagsma, Juanita A, Hammond, Flora M, Hawryluk, Gregory, Hutchinson, Peter, van der Jagt, Mathieu, Jain, Sonia, Jain, Swati, Jiang, Ji-yao, Kent, Hope, Kolias, Angelos, Kompanje, Erwin J O, Lecky, Fiona, Lingsma, Hester F, Maegele, Marc, Majdan, Marek, Markowitz, Amy, McCrea, Michael, Meyfroidt, Geert, Mikolić, Ana, Mondello, Stefania, Mukherjee, Pratik, Nelson, David, Nelson, Lindsay D, Newcombe, Virginia, Okonkwo, David, Orešič, Matej, Peul, Wilco, Pisică, Dana, Polinder, Suzanne, Ponsford, Jennie, Puybasset, Louis, Raj, Rahul, Robba, Chiara, Røe, Cecilie, Rosand, Jonathan, Schueler, Peter, Sharp, David J, Smielewski, Peter, Stein, Murray B, von Steinbüchel, Nicole, Stewart, William, Steyerberg, Ewout W, Stocchetti, Nino, Temkin, Nancy, Tenovuo, Olli, Theadom, Alice, Thomas, Ilias, Espin, Abel Torres, Turgeon, Alexis F, Unterberg, Andreas, Van Praag, Dominique, van Veen, Ernest, Verheyden, Jan, Vyvere, Thijs Vande, Wang, Kevin K W, Wiegers, Eveline J A, Williams, W Huw, Wilson, Lindsay, Wisniewski, Stephen R, Younsi, Alexander, Yue, John, Yuh, Esther L, Zeiler, Frederick A, Zeldovich, Marina, Zemek, Roger, Maas, A, Menon, D, Manley, G, Abrams, M, Åkerlund, C, Andelic, N, Aries, M, Bashford, T, Bell, M, Bodien, Y, Brett, B, Büki, A, Chesnut, R, Citerio, G, Clark, D, Clasby, B, Cooper, D, Czeiter, E, Czosnyka, M, Dams-O'Connor, K, De Keyser, V, Diaz-Arrastia, R, Ercole, A, van Essen, T, Falvey, É, Ferguson, A, Figaji, A, Fitzgerald, M, Foreman, B, Gantner, D, Gao, G, Giacino, J, Gravesteijn, B, Guiza, F, Gupta, D, Gurnell, M, Haagsma, J, Hammond, F, Hawryluk, G, Hutchinson, P, van der Jagt, M, Jain, S, Jiang, J, Kent, H, Kolias, A, Kompanje, E, Lecky, F, Lingsma, H, Maegele, M, Majdan, M, Markowitz, A, Mccrea, M, Meyfroidt, G, Mikolić, A, Mondello, S, Mukherjee, P, Nelson, D, Nelson, L, Newcombe, V, Okonkwo, D, Orešič, M, Peul, W, Pisică, D, Polinder, S, Ponsford, J, Puybasset, L, Raj, R, Robba, C, Røe, C, Rosand, J, Schueler, P, Sharp, D, Smielewski, P, Stein, M, von Steinbüchel, N, Stewart, W, Steyerberg, E, Stocchetti, N, Temkin, N, Tenovuo, O, Theadom, A, Thomas, I, Espin, A, Turgeon, A, Unterberg, A, Van Praag, D, van Veen, E, Verheyden, J, Vyvere, T, Wang, K, Wiegers, E, Williams, W, Wilson, L, Wisniewski, S, Younsi, A, Yue, J, Yuh, E, Zeiler, F, Zeldovich, M, Zemek, R, Maas, Andrew I R, Menon, David K, Manley, Geoffrey T, Abrams, Mathew, Åkerlund, Cecilia, Andelic, Nada, Aries, Marcel, Bashford, Tom, Bell, Michael J, Bodien, Yelena G, Brett, Benjamin L, Büki, András, Chesnut, Randall M, Citerio, Giuseppe, Clark, David, Clasby, Betony, Cooper, D Jamie, Czeiter, Endre, Czosnyka, Marek, Dams-O'Connor, Kristen, De Keyser, Véronique, Diaz-Arrastia, Ramon, Ercole, Ari, van Essen, Thomas A, Falvey, Éanna, Ferguson, Adam R, Figaji, Anthony, Fitzgerald, Melinda, Foreman, Brandon, Gantner, Dashiell, Gao, Guoyi, Giacino, Joseph, Gravesteijn, Benjamin, Guiza, Fabian, Gupta, Deepak, Gurnell, Mark, Haagsma, Juanita A, Hammond, Flora M, Hawryluk, Gregory, Hutchinson, Peter, van der Jagt, Mathieu, Jain, Sonia, Jain, Swati, Jiang, Ji-yao, Kent, Hope, Kolias, Angelos, Kompanje, Erwin J O, Lecky, Fiona, Lingsma, Hester F, Maegele, Marc, Majdan, Marek, Markowitz, Amy, McCrea, Michael, Meyfroidt, Geert, Mikolić, Ana, Mondello, Stefania, Mukherjee, Pratik, Nelson, David, Nelson, Lindsay D, Newcombe, Virginia, Okonkwo, David, Orešič, Matej, Peul, Wilco, Pisică, Dana, Polinder, Suzanne, Ponsford, Jennie, Puybasset, Louis, Raj, Rahul, Robba, Chiara, Røe, Cecilie, Rosand, Jonathan, Schueler, Peter, Sharp, David J, Smielewski, Peter, Stein, Murray B, von Steinbüchel, Nicole, Stewart, William, Steyerberg, Ewout W, Stocchetti, Nino, Temkin, Nancy, Tenovuo, Olli, Theadom, Alice, Thomas, Ilias, Espin, Abel Torres, Turgeon, Alexis F, Unterberg, Andreas, Van Praag, Dominique, van Veen, Ernest, Verheyden, Jan, Vyvere, Thijs Vande, Wang, Kevin K W, Wiegers, Eveline J A, Williams, W Huw, Wilson, Lindsay, Wisniewski, Stephen R, Younsi, Alexander, Yue, John, Yuh, Esther L, Zeiler, Frederick A, Zeldovich, Marina, and Zemek, Roger

Published
2022

22. Deferred Consent in an Acute Stroke Trial from a Patient, Proxy, and Physician Perspective: A Cross-Sectional Survey

Author

Projectafdeling CVZ, Bioethics & Health Humanities, JC onderzoeksprogramma Methodologie, Circulatory Health, Opleiding Neurologie, Neurologen, Brain, Koopman, Inez, Verbaan, Dagmar, Vandertop, W Peter, van der Graaf, Rieke, Kompanje, Erwin J O, Post, René, Coert, Bert A, Ploem, Martine C, Sluis, Wouter M, Scheijmans, Féline E V, Rinkel, Gabriel J E, Vergouwen, Mervyn D I, Projectafdeling CVZ, Bioethics & Health Humanities, JC onderzoeksprogramma Methodologie, Circulatory Health, Opleiding Neurologie, Neurologen, Brain, Koopman, Inez, Verbaan, Dagmar, Vandertop, W Peter, van der Graaf, Rieke, Kompanje, Erwin J O, Post, René, Coert, Bert A, Ploem, Martine C, Sluis, Wouter M, Scheijmans, Féline E V, Rinkel, Gabriel J E, and Vergouwen, Mervyn D I

Published
2022

23. Medical research in emergency research in the European Union member states: tensions between theory and practice

Author

Kompanje, Erwin J. O., Maas, Andrew I. R., Menon, David K., and Kesecioglu, Jozef

Subjects
Medical research -- Political aspects -- Analysis -- Usage -- Laws, regulations and rules, Medicine, Experimental -- Political aspects -- Analysis -- Usage -- Laws, regulations and rules, Patient education -- Political aspects -- Analysis -- Research -- Laws, regulations and rules -- Usage, Government regulation, Health care industry, European Union -- Political activity -- Political aspects, European Union. European Parliament -- Political aspects -- Political activity, European Union. European Commission -- Political aspects -- Political activity
Abstract

In almost all of the European Union member states, prior consent by a legal representative is used as a substitute for informed patient consent for non-urgent medical research. Deferred (patient and/or proxy) consent is accepted as a substitute in acute emergency research in approximately half of the member states. In 12 European Union member states emergency research is not mentioned in national law. Medical research in the European Union is covered by the Clinical Trial Directive 2001/20/EC. A proposal for a regulation by the European Commission is currently being examined by the European Parliament and the Council and will replace Directive 2001/20/EC. Deferred patient and/or proxy consent is allowed in the proposed regulation, but does not fit completely in the practice of emergency research. For example, deferred consent is only possible when legal representatives are not available. This criterion will delay inclusion of patients in acute life-threatening conditions in short time frames. As the regulation shall be binding in its entirety in all member states, emergency research in acute situations is still not possible as it should be., Author(s): Erwin J. O. Kompanje [sup.1], Andrew I. R. Maas [sup.2], David K. Menon [sup.3], Jozef Kesecioglu [sup.4] Author Affiliations: (1) grid.5645.2, 000000040459992X, Department of Intensive Care Medicine, Erasmus MC [...]

Published
2014
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24. How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study

Author

Timmers, Marjolein, Van Dijck, Jeroen T. J. M., Van Wijk, Roel P. J., Legrand, Valerie, Van Veen, Ernest, Maas, Andrew I. R., Menon, David K., Citerio, Giuseppe, Stocchetti, Nino, Kompanje, Erwin J. O., Åkerlund, Cecilia, Amrein, Krisztina, Andelic, Nada, Andreassen, Lasse, Anke, Audny, Antoni, Anna, Audibert, Gérard, Azouvi, Philippe, Azzolini, Maria Luisa, Bartels, Ronald, Barzó, Pál, Beauvais, Romuald, Beer, Ronny, Bellander, Bo-Michael, Belli, Antonio, Benali, Habib, Berardino, Maurizio, Beretta, Luigi, Blaabjerg, Morten, Bragge, Peter, Brazinova, Alexandra, Brinck, Vibeke, Brooker, Joanne, Brorsson, Camilla, Buki, Andras, Bullinger, Monika, Cabeleira, Manuel, Caccioppola, Alessio, Calappi, Emiliana, Calvi, Maria Rosa, Cameron, Peter, Lozano, Guillermo Carbayo, Carbonara, Marco, Cavallo, Simona, Chevallard, Giorgio, Chieregato, Arturo, Ceyisakar, Iris, Coburn, Mark, Coles, Jonathan, Cooper, Jamie D., Correia, Marta, Čović, Amra, Curry, Nicola, Czeiter, Endre, Czosnyka, Marek, Dahyot-Fizelier, Claire, Dark, Paul, Dawes, Helen, De Keyser, Véronique, Degos, Vincent, Corte, Francesco Della, Den Boogert, Hugo, Depreitere, Bart, Đilvesi, Đula, Dixit, Abhishek, Donoghue, Emma, Dreier, Jens, Dulière, Guy-Loup, Ercole, Ari, Esser, Patrick, Ezer, Erzsébet, Fabricius, Martin, Feigin, Valery L., Foks, Kelly, Frisvold, Shirin, Furmanov, Alex, Gagliardo, Pablo, Galanaud, Damien, Gantner, Dashiell, Gao, Guoyi, George, Pradeep, Ghuysen, Alexandre, Giga, Lelde, Glocker, Ben, Golubovic, Jagoš, Gomez, Pedro A., Gratz, Johannes, Gravesteijn, Benjamin, Grossi, Francesca, Gruen, Russell L., Gupta, Deepak, Haagsma, Juanita A., Haitsma, Iain, Helbok, Raimund, Helseth, Eirik, Horton, Lindsay, Huijben, Jilske, Hutchinson, Peter J., Jacobs, Bram, Jankowski, Stefan, Jarrett, Mike, Jiang, Ji-Yao, Johnson, Faye, Jones, Kelly, Karan, Mladen, Kolias, Angelos G., Kompanje, Erwin, Kondziella, Daniel, Koraropoulos, Evgenios, Koskinen, Lars-Owe, Kovács, Noémi, Kowark, Ana, Lagares, Alfonso, Lanyon, Linda, Laureys, Steven, Lecky, Fiona, Ledoux, Didier, Lefering, Rolf, Lejeune, Aurelie, Levi, Leon, Lightfoot, Roger, Lingsma, Hester, Castaño-León, Ana M., Maegele, Marc, Majdan, Marek, Manara, Alex, Manley, Geoffrey, Martino, Costanza, Maréchal, Hugues, Mattern, Julia, McMahon, Catherine, Melegh, Béla, Menon, David, Menovsky, Tomas, Misset, Benoit, Mulazzi, Davide, Muraleedharan, Visakh, Murray, Lynnette, Negru, Ancuta, Nelson, David, Newcombe, Virginia, Nieboer, Daan, Nyirádi, József, Olubukola, Otesile, Oresic, Matej, Ortolano, Fabrizio, Palotie, Aarno, Parizel, Paul M., Payen, Jean-François, Perera, Natascha, Perlbarg, Vincent, Persona, Paolo, Peul, Wilco, Piippo-Karjalainen, Anna, Pirinen, Matti, Ples, Horia, Polinder, Suzanne, Pomposo, Inigo, Posti, Jussi P., Puybasset, Louis, Radoi, Andreea, Ragauskas, Arminas, Raj, Rahul, Rambadagalla, Malinka, Rhodes, Jonathan, Richardson, Sylvia, Richter, Sophie, Ripatti, Samuli, Rocka, Saulius, Roe, Cecilie, Roise, Olav, Rosand, Jonathan, Rosenfeld, Jeffrey V., Rosenlund, Christina, Rosenthal, Guy, Rossaint, Rolf, Rossi, Sandra, Rueckert, Daniel, Rusnák, Martin, Sahuquillo, Juan, Sakowitz, Oliver, Sanchez-Porras, Renan, Sandor, Janos, Schäfer, Nadine, Schmidt, Silke, Schoechl, Herbert, Schoonman, Guus, Schou, Rico Frederik, Schwendenwein, Elisabeth, Sewalt, Charlie, Skandsen, Toril, Smielewski, Peter, Sorinola, Abayomi, Stamatakis, Emmanuel, Stanworth, Simon, Stevens, Robert, Stewart, William, Steyerberg, Ewout W., Sundström, Nina, Synnot, Anneliese, Takala, Riikka, Tamás, Viktória, Tamosuitis, Tomas, Taylor, Mark Steven, Ao, Braden Te, Tenovuo, Olli, Theadom, Alice, Thomas, Matt, Tibboel, Dick, Tolias, Christos, Trapani, Tony, Tudora, Cristina Maria, Vajkoczy, Peter, Vallance, Shirley, Valeinis, Egils, Vámos, Zoltán, Van Der Steen, Gregory, Van Der Naalt, Joukje, Van Essen, Thomas A., Van Hecke, Wim, Van Heugten, Caroline, Van Praag, Dominique, Vyvere, Thijs Vande, Vargiolu, Alessia, Vega, Emmanuel, Velt, Kimberley, Verheyden, Jan, Vespa, Paul M., Vik, Anne, Vilcinis, Rimantas, Volovici, Victor, Von Steinbüchel, Nicole, Voormolen, Daphne, Vulekovic, Petar, Wang, Kevin K. W., Wiegers, Eveline, Williams, Guy, Wilson, Lindsay, Winzeck, Stefan, Wolf, Stefan, Yang, Zhihui, Ylén, Peter, Younsi, Alexander, Zeiler, Frederick A., Zelinkova, Veronika, Ziverte, Agate, Zoerle, Tommaso, Kompanje, Erwin J. O. [0000-0002-0649-4019], and Apollo - University of Cambridge Repository

Subjects
Health-care research, Harmonization, health services administration, education, CENTER-TBI, Research ethic committees, European Union, Ethics in Biomedical Research, health care economics and organizations, humanities, Research Article
Abstract

Background: The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency. Methods: We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results: From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75–224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074). Conclusion: We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.

Published
2020

28. The first historical description of chronic subdural hematoma: A tale of inaccurate interpretation, inaccurate quoting and inaccurate requoting.

Author

Dammers, Ruben, Holl, Dana C., Kapiteijn, Brenda, and Kompanje, Erwin J. O.

Abstract

Most historical articles have named Johann Jacob Wepfer as the first author to describe a case of chronic subdural hematoma (CSDH). However, the question arises whether these cases truly describe CSDH. Two other names that appear in literature as the first authors to describe a case of CSDH are Thomas Willis and Giovanni Battista Morgagni. In our attempt to find the first description of a CSDH, we studied the original cases described by Willis, Wepfer, and Morgagni. The cases described by Willis and Wepfer cannot be interpreted as cases of CSDH. Willis's university scholar is more likely to have experienced venous infarction with an underlying septic thrombosis than a CSDH. Wepfer's cases seem to represent an intraparenchymal hemorrhage from the rupture of a branch or branches of the internal carotid artery, a subarachnoid hemorrhage complicated with hydrocephalus, and a hydrocephalus in tuberculous meningitis. Morgagni's case described in Letter III, Article 20 in the Sedibus in 1761 seems to be the first accurate historical description of a CSDH, and we believe it should be cited as such. With these early cases of alleged CSDH, we emphasize the importance of misquotation and blind copying of references, which are important citation errors. [ABSTRACT FROM AUTHOR]

Published
2023
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29. Deferred Consent in an Acute Stroke Trial from a Patient, Proxy, and Physician Perspective: A Cross-Sectional Survey

Author

Koopman, Inez, primary, Verbaan, Dagmar, additional, Vandertop, W. Peter, additional, van der Graaf, Rieke, additional, Kompanje, Erwin J. O., additional, Post, René, additional, Coert, Bert A., additional, Ploem, Martine C., additional, Sluis, Wouter M., additional, Scheijmans, Féline E. V., additional, Rinkel, Gabriel J. E., additional, and Vergouwen, Mervyn D. I., additional

Published
2021
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38. Additional file 4 of Outcomes of ICU patients with and without perceptions of excessive care: a comparison between cancer and non-cancer patients

Author

Benoit, Dominique D., van der Zee, Esther N., Darmon, Michael, Reyners, An K. L., Metaxa, Victoria, Mokart, Djamel, Wilmer, Alexander, Depuydt, Pieter, Hvarfner, Andreas, Rusinova, Katerina, Zijlstra, Jan G., Vincent, François, Lathyris, Dimitrios, Meert, Anne-Pascale, Devriendt, Jacques, Uyttersprot, Emma, Kompanje, Erwin J. O., Piers, Ruth, and Azoulay, Elie

Subjects
health care facilities, manpower, and services
Abstract

Additional file 4: Fig. S2. a Time from ICU admission until at least 2 PECs during ICU stay (unweighted). b Time from ICU admission until death (unweighted). C Time from ICU admission until TLD during ICU stay (unweighted). TLD: treatment limitation decision, PEC: Perceptions of Excessive Care.

Published
2021
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39. Additional file 2 of Outcomes of ICU patients with and without perceptions of excessive care: a comparison between cancer and non-cancer patients

Author

Benoit, Dominique D., van der Zee, Esther N., Darmon, Michael, Reyners, An K. L., Metaxa, Victoria, Mokart, Djamel, Wilmer, Alexander, Depuydt, Pieter, Hvarfner, Andreas, Rusinova, Katerina, Zijlstra, Jan G., Vincent, François, Lathyris, Dimitrios, Meert, Anne-Pascale, Devriendt, Jacques, Uyttersprot, Emma, Kompanje, Erwin J. O., Piers, Ruth, and Azoulay, Elie

Abstract

Additional file 2. Master dissertation of E. Uyttersprot.

Published
2021
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40. Additional file 5 of Outcomes of ICU patients with and without perceptions of excessive care: a comparison between cancer and non-cancer patients

Author

Benoit, Dominique D., van der Zee, Esther N., Darmon, Michael, Reyners, An K. L., Metaxa, Victoria, Mokart, Djamel, Wilmer, Alexander, Depuydt, Pieter, Hvarfner, Andreas, Rusinova, Katerina, G.Zijlstra, Jan, Vincent, François, Lathyris, Dimitrios, Meert, Anne-Pascale, Devriendt, Jacques, Uyttersprot, Emma, Kompanje, Erwin J. O., Piers, Ruth, and Azoulay, Elie

Abstract

Additional file 5: Table S3. Mortality and TLDs across subgroups (unweighted results)

Published
2021
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41. Additional file 1 of Outcomes of ICU patients with and without perceptions of excessive care: a comparison between cancer and non-cancer patients

Author

Benoit, Dominique D., van der Zee, Esther N., Darmon, Michael, Reyners, An K. L., Metaxa, Victoria, Mokart, Djamel, Wilmer, Alexander, Depuydt, Pieter, Hvarfner, Andreas, Rusinova, Katerina, G.Zijlstra, Jan, Vincent, François, Lathyris, Dimitrios, Meert, Anne-Pascale, Devriendt, Jacques, Uyttersprot, Emma, Kompanje, Erwin J. O., Piers, Ruth, and Azoulay, Elie

Subjects
Data_FILES
Abstract

Additional file 1. Definitions of collected data.

Published
2021
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42. Additional file 3 of Outcomes of ICU patients with and without perceptions of excessive care: a comparison between cancer and non-cancer patients

Author

Benoit, Dominique D., van der Zee, Esther N., Darmon, Michael, Reyners, An K. L., Metaxa, Victoria, Mokart, Djamel, Wilmer, Alexander, Depuydt, Pieter, Hvarfner, Andreas, Rusinova, Katerina, Zijlstra, Jan G., Vincent, François, Lathyris, Dimitrios, Meert, Anne-Pascale, Devriendt, Jacques, Uyttersprot, Emma, Kompanje, Erwin J. O., Piers, Ruth, and Azoulay, Elie

Subjects
genetic structures, sense organs, behavioral disciplines and activities, psychological phenomena and processes
Abstract

Additional file 3: Fig. S1. Flowchart study unweighted results: number of ICU’s, clinicians, perceptions and patients. PEC: Perceptions of Excessive Care. Combined endpoint: death, poor quality of life or not being at home.

Published
2021
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44. One-year Mortality of Cancer Patients with an Unplanned ICU Admission: A Cohort Analysis Between 2008 and 2017 in the Netherlands.

Author

van der Zee, Esther N., Termorshuizen, Fabian, Benoit, Dominique D., de Keizer, Nicolette F., Bakker, Jan, Kompanje, Erwin J. O., Rietdijk, Wim J. R., and Epker, Jelle L.

Subjects
CANCER patients, INTENSIVE care patients, CRITICAL care medicine, TUMORS, CANCER
Abstract

Introduction: A decrease in short-term mortality of critically ill cancer patients with an unplanned intensive care unit (ICU) admission has been described. Few studies describe a change over time of 1-year mortality. Therefore, we examined the 1-year mortality of cancer patients (hematological or solid) with an unplanned ICU admission and we described whether the mortality changed over time. Methods: We used the National Intensive Care Evaluation (NICE) registry and extracted all patients with an unplanned ICU admission in the Netherlands between 2008 and 2017. The primary outcome was 1-year mortality, analyzed with a mixed-effects Cox proportional hazard regression. We compared the 1-year mortality of cancer patients to that of patients without cancer. Furthermore, we examined changes in mortality over the study period. Results: We included 470,305 patients: 10,401 with hematological cancer, 35,920 with solid cancer, and 423,984 without cancer. The 1-year mortality rates were 60.1%, 46.2%, and 28.3% respectively (P< .01). Approximately 30% of the cancer patients surviving their hospital admission died within 1 year, this was 12% in patients without cancer. In hematological patients, 1-year mortality decreased between 2008 and 2011, after which it stabilized. In solid cancer patients, inspection showed neither an increasing nor decreasing trend over the inclusion period. For patients without cancer, 1-year mortality decreased between 2008 and 2013, after which it stabilized. A clear decrease in hospital mortality was seen within all three groups. Conclusion: The 1-year mortality of cancer patients with an unplanned ICU admission (hematological and solid) was higher than that of patients without cancer. About one-third of the cancer patients surviving their hospital admission died within 1 year after ICU admission. We found a decrease in 1-year mortality until 2011 in hematology patients and no decrease in solid cancer patients. Our results suggest that for many cancer patients, an unplanned ICU admission is still a way to recover from critical illness, and it does not necessarily lead to success in long-term survival. The underlying type of malignancy is an important factor for long-term outcomes in patients recovering from critical illness. [ABSTRACT FROM AUTHOR]

Published
2022
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46. How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study

Author

CTR-TBI Investigators Participants, Timmers, Marjolein, van Dijck, Jeroen T. J. M., van Wijk, Roel P. J., Kompanje, Erwin J. O., Palotie, Aarno, Piippo-Karjalainen, Anna, Pirinen, Matti, Posti, Jussi P., Raj, Rahul, Tenovuo, Olli, Ripatti, Samuli, Centre of Excellence in Complex Disease Genetics, Research Programme of Molecular Medicine, Aarno Palotie / Principal Investigator, Institute for Molecular Medicine Finland, Genomics of Neurological and Neuropsychiatric Disorders, University of Helsinki, HUS Neurocenter, Neurokirurgian yksikkö, Helsinki Institute for Information Technology, Statistical and population genetics, Department of Mathematics and Statistics, Biostatistics Helsinki, Clinicum, Helsinki University Hospital Area, Department of Public Health, Samuli Olli Ripatti / Principal Investigator, Complex Disease Genetics, and University Management

Subjects
Health-care research, HARMONIZATION, health services administration, education, MULTICENTER, CENTER-TBI, Research ethic committees, European Union, 3111 Biomedicine, CARE, health care economics and organizations, humanities
Abstract

Background The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency. Methods We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75-224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074). Conclusion We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.

Published
2020

47. Occurrence and timing of withdrawal of life-sustaining measures in traumatic brain injury patients: a CENTER-TBI study

Author

van Veen, E, van der Jagt, M, Citerio, G, Stocchetti, N, Gommers, D, Burdorf, A, Menon, D, Maas, A, Kompanje, E, Lingsma, H, van Veen, Ernest, van der Jagt, Mathieu, Citerio, Giuseppe, Stocchetti, Nino, Gommers, Diederik, Burdorf, Alex, Menon, David K, Maas, Andrew I R, Kompanje, Erwin J O, Lingsma, Hester F, van Veen, E, van der Jagt, M, Citerio, G, Stocchetti, N, Gommers, D, Burdorf, A, Menon, D, Maas, A, Kompanje, E, Lingsma, H, van Veen, Ernest, van der Jagt, Mathieu, Citerio, Giuseppe, Stocchetti, Nino, Gommers, Diederik, Burdorf, Alex, Menon, David K, Maas, Andrew I R, Kompanje, Erwin J O, and Lingsma, Hester F

Abstract

Background: In patients with severe brain injury, withdrawal of life-sustaining measures (WLSM) is common in intensive care units (ICU). WLSM constitutes a dilemma: instituting WLSM too early could result in death despite the possibility of an acceptable functional outcome, whereas delaying WLSM could unnecessarily burden patients, families, clinicians, and hospital resources. We aimed to describe the occurrence and timing of WLSM, and factors associated with timing of WLSM in European ICUs in patients with traumatic brain injury (TBI). Methods: The CENTER-TBI Study is a prospective multi-center cohort study. For the current study, patients with traumatic brain injury (TBI) admitted to the ICU and aged 16 or older were included. Occurrence and timing of WLSM were documented. For the analyses, we dichotomized timing of WLSM in early (< 72 h after injury) versus later (≥ 72 h after injury) based on recent guideline recommendations. We assessed factors associated with initiating WLSM early versus later, including geographic region, center, patient, injury, and treatment characteristics with univariable and multivariable (mixed effects) logistic regression. Results: A total of 2022 patients aged 16 or older were admitted to the ICU. ICU mortality was 13% (n = 267). Of these, 229 (86%) patients died after WLSM, and were included in the analyses. The occurrence of WLSM varied between regions ranging from 0% in Eastern Europe to 96% in Northern Europe. In 51% of the patients, WLSM was early. Patients in the early WLSM group had a lower maximum therapy intensity level (TIL) score than patients in the later WLSM group (median of 5 versus 10) The strongest independent variables associated with early WLSM were one unreactive pupil (odds ratio (OR) 4.0, 95% confidence interval (CI) 1.3–12.4) or two unreactive pupils (OR 5.8, CI 2.6–13.1) compared to two reactive pupils, and an Injury Severity Score (ISS) if over 41 (OR per point above 41 = 1.1, CI 1.0–1.1). Timing of WLSM wa

Published
2021

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