Patients and relatives' point of view on the choice of outcomes for a randomized-controlled trial in moderate-to-severe Traumatic Brain Injury

被引：0

作者：

Chatelain, Guillaume ^{[1
]}

Derouin, Yvan ^{[2
,3
]}

Cinotti, Raphael ^{[2
,3
]}

机构：

[1] Hop St Jacques, France Cerebro Les, Assoc Familles Traumatises Craniens & Cerebro Lese, F-44000 Nantes, France

[2] Nantes Univ, Serv Anesthesie Reanimat, CHU Nantes, Hotel Dieu, F-44000 Nantes, France

[3] Tours Univ, Nantes Univ, UMR MethodS Patients Ctr Outcomes & Hlth Res 1246, SPHERE, F-44000 Nantes, France

来源：

ANAESTHESIA CRITICAL CARE & PAIN MEDICINE | 2025年 / 44卷 / 04期

关键词：

Traumatic Brain Injury; Post-intensive care syndrome; Patient-centred outcome; Core outcome set; CARE;

D O I：

10.1016/j.accpm.2025.101533

中图分类号：

R614 [麻醉学];

学科分类号：

100217 ;

摘要：

Traumatic Brain Injury (TBI) is a major cause of mortality and disability worldwide. Clinical research is a cornerstone to improve patients' outcomes. The empowerment of patients and relatives in research initiatives is now recommended to improve the relevance of trials. We performed an online survey in collaboration with the French National Association of Patients with Brain Injury (France Cerebrolesion) from November to December 2024, to understand their point of view regarding potential outcomes that could qualify hypertonic saline perfusion as relevant in the coming multicentric randomized-controlled COSMOS trial involving 760 moderate-to-severe TBI. 32 persons responded (19 (59.4%) relatives and 13 (40.6%) former patients). Using a 5-grade Likert scale, 23 (71.9%) responders rather agreed or entirely agreed that mortality was a relevant outcome; 26 (81.3%) rated activities of daily living as relevant; 27 (84.4%) rated cognitive function as relevant; 30 (93.7%) rated memory function as relevant; 17 (53.2%) rated functional outcome as relevant; 26 (81.3%) rated anxiety and depression symptoms as relevant; 27 (84.4%) rated quality of life as relevant. Ten (31.3%) responders could not understand the concept of functional outcome. The highest-ranked outcomes were mortality (16 responders gave the highest mark of 7), activities in daily living (14 responders), and memory (11 responders). Although this survey does not have the value of a consensus and further studies are needed to encompass other stakeholders' opinions, we have modified the primary outcomes in COSMOS: functional outcome has been replaced by a hierarchy with 1/ survival and 2/activities in daily living. (C) 2025 The Author(s). Published by Elsevier Masson SAS on behalf of Societe Francaise d'Anesthesie et de Reanimation (SFAR). This is an open access article under the CC BY license (http://creativecommons.org/ licenses/by/4.0/).

引用

页数：4

共 19 条

[1] Understanding factors impacting patient-reported outcome measures integration in routine clinical practice: an umbrella review [J].

Anderson, Michael ;

van Kessel, Robin ;

Wood, Eleanor ;

Stokes, Adam ;

Fistein, Jon ;

Porter, Ian ;

Mossialos, Elias ;

Valderas, Jose M. .

QUALITY OF LIFE RESEARCH, 2024, 33 (10) :2611-2629

[2] Hypothermia for Intracranial Hypertension after Traumatic Brain Injury [J].

Andrews, Peter J. D. ;

Sinclair, H. Louise ;

Rodriguez, Aryelly ;

Harris, Bridget A. ;

Battison, Claire G. ;

Rhodes, Jonathan K. J. ;

Murray, Gordon D. .

NEW ENGLAND JOURNAL OF MEDICINE, 2015, 373 (25) :2403-2412

[3] The Integration of Clinical Trials With the Practice of Medicine: Repairing a House Divided [J].

Angus, Derek C. ;

Huang, Alison J. ;

Lewis, Roger J. ;

Abernethy, Amy P. ;

Califf, Robert M. ;

Landray, Martin ;

Kass, Nancy ;

Bibbins-Domingo, Kirsten .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2024, 332 (02) :153-162

[4] How to increase value and reduce waste when research priorities are set [J].

Chalmers, Iain ;

Bracken, Michael B. ;

Djulbegovic, Ben ;

Garattini, Silvio ;

Grant, Jonathan ;

Guelmezoglu, A. Metin ;

Howells, David W. ;

Ioannidis, John P. A. ;

Oliver, Sandy .

LANCET, 2014, 383 (9912) :156-165

[5] Standardized Outcomes for Randomized Controlled Trials Targeting Early Interventions in Patients With Moderate-to-Severe Traumatic Brain Injury: Protocol for the Development of a Core Outcome Set [J].

Cinotti, Raphael ;

Derouin, Yvan ;

Chenet, Amandine ;

Oujamaa, Lydia ;

Glize, Bertrand ;

Launey, Yoann ;

Dahyot-Fizelier, Claire ;

Cartron, Emmanuelle ;

Renvoise, Melodie ;

Sautenet, Benedicte ;

Sebille, Veronique .

JMIR RESEARCH PROTOCOLS, 2025, 14

[6] Anxiety and depression symptoms in relatives of moderate-to-severe traumatic brain injury survivors - A multicentre cohort [J].

Cinotti, Raphael ;

Chopin, Alice ;

Moyer, Jean Denis ;

Huet, Olivier ;

Lasocki, Sigismond ;

Cohen, Benjamin ;

Dahyot-Fizelier, Claire ;

Chalard, Kevin ;

Seguin, Philippe ;

Martin, Florian Pierre ;

Lerebourg, Celine ;

Guitteny, Marie ;

Chenet, Amandine ;

Perrouin-Verbe, Brigitte ;

Asehnoune, Karim ;

Feuillet, Fanny ;

Sebille, Veronique ;

Roquilly, Antoine .

ANAESTHESIA CRITICAL CARE & PAIN MEDICINE, 2023, 42 (05)

[7] Relationship between health-related quality-of-life and functional outcome 6 months after moderate to severe TBI. [J].

Cinotti, Raphael ;

Roquilly, Antoine ;

Chopin, Alice ;

Martin, Florian Pierre ;

Morato, Yoanna ;

Lerebourg, Celine ;

Moyer, Jean Denis ;

Huet, Olivier ;

Lasocki, Sigismond ;

Cohen, Benjamin ;

Dahyot-Fizelier, Claire ;

Chalard, Kevin ;

Seguin, Philippe ;

Chenet, Amandine ;

Perrouin-Verbe, Brigitte ;

Sinha, Debajyoti ;

Asehnoune, Karim ;

Feuillet, Fanny ;

Sebille, Veronique .

ANNALS OF PHYSICAL AND REHABILITATION MEDICINE, 2023, 66 (05)

[8] Stress Ulcer Prophylaxis during Invasive Mechanical Ventilation [J].

Cook, D. ;

Deane, A. ;

Lauzier, F. ;

Zytaruk, N. ;

Guyatt, G. ;

Saunders, L. ;

Hardie, M. ;

Heels-Ansdell, D. ;

Alhazzani, W. ;

Marshall, J. ;

Myburgh, J. ;

Muscedere, J. ;

English, S. ;

Arabi, Y. M. ;

Ostermann, M. ;

Knowles, S. ;

Hammond, N. ;

Byrne, K. M. ;

Chapman, M. ;

Venkatesh, B. ;

Young, P. ;

Rajbhandari, D. ;

Poole, A. ;

Al-Fares, A. ;

Reis, G. ;

Johnson, D. ;

Iqbal, M. ;

Hall, R. ;

Meade, M. ;

Hand, L. ;

Duan, E. ;

Clarke, F. ;

Dionne, J. C. ;

Tsang, J. L. Y. ;

Rochwerg, B. ;

Karachi, T. ;

Lamontagne, F. ;

D'Aragon, F. ;

St Arnaud, C. ;

Reeve, B. ;

Geagea, A. ;

Niven, D. ;

Vazquez-Grande, G. ;

Zarychanski, R. ;

Ovakim, D. ;

Wood, G. ;

Burns, K. E. A. ;

Goffi, A. ;

Wilcox, M. E. ;

Henderson, W. .

NEW ENGLAND JOURNAL OF MEDICINE, 2024, 391 (01) :9-20

[9] A Systematic Review of Reported Outcomes in Randomized Controlled Trials Targeting Early Interventions in Moderate-to-Severe Traumatic Brain Injury [J].

Derouin, Yvan ;

Delhomme, Thomas ;

Launey, Yoann ;

Bouras, Marwan ;

Sautenet, Benedicte ;

Sebille, Veronique ;

Cinotti, Raphael .

JOURNAL OF NEUROTRAUMA, 2024, 41 (19-20) :2238-2247

[10] Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey [J].

Evangelidis, Nicole ;

Tong, Allison ;

Manns, Braden ;

Hemmelgarn, Brenda ;

Wheeler, David C. ;

Tugwell, Peter ;

Crowe, Sally ;

Harris, Tess ;

Van Biesen, Wim ;

Winkelmayer, Wolfgang C. ;

Sautenet, Benedicte ;

O'Donoghue, Donal ;

Tam-Tham, Helen ;

Youssouf, Sajeda ;

Mandayam, Sreedhar ;

Ju, Angela ;

Hawley, Carmel ;

Pollock, Carol ;

Harris, David C. ;

Johnson, David W. ;

Rifkin, Dena E. ;

Tentori, Francesca ;

Agar, John ;

Polkinghorne, Kevan R. ;

Gallagher, Martin ;

Kerr, Peter G. ;

McDonald, Stephen P. ;

Howard, Kirsten ;

Howell, Martin ;

Craig, Jonathan C. .

AMERICAN JOURNAL OF KIDNEY DISEASES, 2017, 70 (04) :464-475

← 1 2 →