TY - JOUR
T1 - Common Data Elements for Disorders of Consciousness
T2 - Recommendations from the Working Group on Outcomes and Endpoints
AU - the Curing Coma Campaign, its Contributing Members
AU - Bodien, Yelena G.
AU - LaRovere, Kerri
AU - Kondziella, Daniel
AU - Taran, Shaurya
AU - Estrano, Anna
AU - Shutter, Lori
AU - Zink, Elizabeth
AU - Zimmerman, Lara
AU - Ziai, Wendy
AU - Zhang, Bei
AU - Zammit, Chris
AU - Zahuranec, Darin
AU - Zafonte, Ross
AU - Yakhind, Aleksandra
AU - Witherspoon, Briana
AU - Whyte, John
AU - Wainwright, Mark
AU - Wagner, Amy
AU - Vox, Ford
AU - Voss, Henning
AU - Videtta, Walter
AU - Vespa, Paul
AU - Varelas, Panos
AU - Udy, Andrew
AU - Turgeon, Alexis
AU - Trevick, Stephen
AU - Torbey, Michel
AU - Toker, Daniel
AU - Tinti, Lorenzo
AU - Threlkeld, Zachary
AU - Thibaut, Aurore
AU - Sussman, Bethany
AU - Suarez, Jose
AU - Stevens, Robert
AU - Steinberg, Alexis
AU - Stamatakis, Emmanuel
AU - Smith, Wade
AU - Smielewski, Peter
AU - Slomine, Beth
AU - Sitt, Jacobo
AU - Sharshar, Tarek
AU - Sharma, Kartavya
AU - Shapshak, Angela
AU - Shapiro-Rosen, Amy
AU - Shah, Vishank
AU - Seder, David
AU - Schnakers, Caroline
AU - Schiff, Nicolas
AU - Sarwal, Aarti
AU - Sarasso, Simone
AU - Sanz, Leandro
AU - Silva, Gisele Sampaio
AU - Russell, Mary Beth
AU - Rosenthal, Eric
AU - Rosanova, Mario
AU - Rolston, John
AU - Rohaut, Benjamin
AU - Robertson, Courtney
AU - Robba, Chiara
AU - Shinotsuka, Cassia Righy
AU - Shinotsuka, Cassia Righy
AU - Richardson, Risa
AU - Reznik, Michael
AU - Rass, Verena
AU - Rasmussen, Lindsay
AU - Rao, Chethan
AU - Puybasset, Louis
AU - Provencio, Javier
AU - Prisco, Lara
AU - Spivack, Marilyn Price
AU - Pouratian, Nader
AU - Polizzotto, Len
AU - Pergakis, Melissa
AU - Park, Soojin
AU - Padayachy, Llewellyn
AU - Owen, Adrian
AU - Othman, Marwan
AU - Olson, Dai Wai
AU - Nyquist, Paul
AU - Noronha-Falcão, Filipa
AU - Niznick, Naomi
AU - Nielsen, Niklas
AU - Newcombe, Virginia
AU - Natarajan, Girija
AU - Nairon, Emerson
AU - Nagayama, Masao
AU - Naccache, Lionel
AU - Murtaugh, Brooke
AU - Muehlschlegel, Susanne
AU - Morrison, Chris
AU - Monti, Martin
AU - Molteni, Erika
AU - Moheet, Asma
AU - Moberg, Dick
AU - Mijangos, Julio
AU - Meyfroidt, Geert
AU - Menon, David
AU - Mejia-Mantilla, Jorge
AU - McNett, Molly
AU - McCredie, Victoria
AU - Mayer, Stephan
AU - Massimini, Marcello
AU - Ribeiro, Rennan Martins
AU - Maldonado, Nelson
AU - Mainali, Shraddha
AU - Mahanes, Dea
AU - Maddux, Craig
AU - Madden, Lori
AU - Luppi, Andrea
AU - Livesay, Sarah
AU - Ling, Geoffrey
AU - Liang, John
AU - Lewis, Ariane
AU - Lejeune, Nicolas
AU - Lawson, Thomas
AU - Laureys, Steven
AU - Kurtz, Pedro
AU - Kumar, Abhay
AU - Kromm, Julie
AU - Kreitzer, Natalie
AU - Ko, Nerissa
AU - Kirschen, Matt
AU - Kirsch, Hannah
AU - Kim, Keri
AU - Kim, Jenn
AU - Keogh, Maggie
AU - Keller, Emanuela
AU - Jones, Morgan
AU - Janas, Anna
AU - James, Michael L.
AU - Jaffa, Matthew
AU - Illes, Judy
AU - Hwang, David
AU - Human, Theresa
AU - Hu, Xiao
AU - Hu, Peter
AU - Hocker, Sarah
AU - Hirsch, Karen
AU - Hinson, H. E.
AU - Hemphill, Claude
AU - Hassan, Ahmed
AU - Hartings, Jed
AU - Hanley, Daniel
AU - Hammond, Flora
AU - Hakimi, Ryan
AU - Hahn, Cecil
AU - Guanci, Mary
AU - Greer, David
AU - Green, Theresa
AU - Gosseries, Olivia
AU - Gilmore, Emily
AU - Gibbons, Christie
AU - Giacino, Joseph
AU - Ghavam, Ahmeneh
AU - Ganesan, Rishi
AU - Frontera, Jennifer
AU - Foreman, Brandon
AU - Fins, Joseph
AU - Fink, Ericka
AU - Fernandez-Espejo, Davinia
AU - Ferioli, Simona
AU - Farrokh, Salia
AU - Falcone, Guido
AU - Estraneo, Anna
AU - Ercole, Ari
AU - Edlow, Brian
AU - Dullaway, James
AU - Diringer, Michael
AU - Desai, Masoom
AU - Der-Nigoghossian, Caroline
AU - DeGeorgia, Michael
AU - Dangayach, Neha
AU - Creutzfeldt, Claire
AU - Cosmas, Katie
AU - Condie, Chad
AU - Claassen, Jan
AU - Citerio, Giuseppe
AU - Chou, Sherry
AU - Cediel, Emilio
AU - Carroll, Elizabeth
AU - Caceres, Eder
AU - Brown, Emery
AU - Bonnel, Alexandra
AU - Boly, Melanie
AU - Boerwinkle, Varina
AU - Bodien, Yelena
AU - Bleck, Thomas
AU - Berlin, Tracey
AU - Beqiri, Erta
AU - Bell, Kathleen
AU - Beghi, Ettore
AU - Beekman, Rachel
AU - Barra, Megan
AU - Balu, Ram
AU - Badjiata, Neeraj
AU - Bader, Mary Kay
AU - Gebre, Meron Awraris
AU - Appavu, Brian
AU - Amiri, Moshagan
AU - Alkhachroum, Ayham
N1 - Publisher Copyright:
© Springer Science+Business Media, LLC, part of Springer Nature and Neurocritical Care Society 2024.
PY - 2024/10
Y1 - 2024/10
N2 - Background: Clinical management of persons with disorders of consciousness (DoC) is dedicated largely to optimizing recovery. However, selecting a measure to evaluate the extent of recovery is challenging because few measures are designed to precisely assess the full range of potential outcomes, from prolonged DoC to return of preinjury functioning. Measures that are designed specifically to assess persons with DoC are often performance-based and only validated for in-person use. Moreover, there are no published recommendations addressing which outcome measures should be used to evaluate DoC recovery. The resulting inconsistency in the measures selected by individual investigators to assess outcome prevents comparison of results across DoC studies. The National Institute of Neurological Disorders and Stroke (NINDS) common data elements (CDEs) is an amalgamation of standardized variables and tools that are recommended for use in studies of neurologic diseases and injuries. The Neurocritical Care Society Curing Coma Campaign launched an initiative to develop CDEs specifically for DoC and invited our group to recommend CDE outcomes and endpoints for persons with DoCs. Methods: The Curing Coma Campaign Outcomes and Endpoints CDE Workgroup, consisting of experts in adult and pediatric neurocritical care, neurology, and neuroscience, used a previously established five-step process to identify and select candidate CDEs: (1) review of existing NINDS CDEs, (2) nomination and systematic vetting of new CDEs, (3) CDE classification, (4) iterative review and approval of panel recommendations, and (5) development of case report forms. Results: Among hundreds of existing NINDS outcome and endpoint CDE measures, we identified 20 for adults and 18 for children that can be used to assess the full range of recovery from coma. We also proposed 14 new outcome and endpoint CDE measures for adults and 5 for children. Conclusions: The DoC outcome and endpoint CDEs are a starting point in the broader effort to standardize outcome evaluation of persons with DoC. The ultimate goal is to harmonize DoC studies and allow for more precise assessment of outcomes after severe brain injury or illness. An iterative approach is required to modify and adjust these outcome and endpoint CDEs as new evidence emerges.
AB - Background: Clinical management of persons with disorders of consciousness (DoC) is dedicated largely to optimizing recovery. However, selecting a measure to evaluate the extent of recovery is challenging because few measures are designed to precisely assess the full range of potential outcomes, from prolonged DoC to return of preinjury functioning. Measures that are designed specifically to assess persons with DoC are often performance-based and only validated for in-person use. Moreover, there are no published recommendations addressing which outcome measures should be used to evaluate DoC recovery. The resulting inconsistency in the measures selected by individual investigators to assess outcome prevents comparison of results across DoC studies. The National Institute of Neurological Disorders and Stroke (NINDS) common data elements (CDEs) is an amalgamation of standardized variables and tools that are recommended for use in studies of neurologic diseases and injuries. The Neurocritical Care Society Curing Coma Campaign launched an initiative to develop CDEs specifically for DoC and invited our group to recommend CDE outcomes and endpoints for persons with DoCs. Methods: The Curing Coma Campaign Outcomes and Endpoints CDE Workgroup, consisting of experts in adult and pediatric neurocritical care, neurology, and neuroscience, used a previously established five-step process to identify and select candidate CDEs: (1) review of existing NINDS CDEs, (2) nomination and systematic vetting of new CDEs, (3) CDE classification, (4) iterative review and approval of panel recommendations, and (5) development of case report forms. Results: Among hundreds of existing NINDS outcome and endpoint CDE measures, we identified 20 for adults and 18 for children that can be used to assess the full range of recovery from coma. We also proposed 14 new outcome and endpoint CDE measures for adults and 5 for children. Conclusions: The DoC outcome and endpoint CDEs are a starting point in the broader effort to standardize outcome evaluation of persons with DoC. The ultimate goal is to harmonize DoC studies and allow for more precise assessment of outcomes after severe brain injury or illness. An iterative approach is required to modify and adjust these outcome and endpoint CDEs as new evidence emerges.
KW - Coma
KW - Common data elements
KW - Consciousness
KW - Outcome
KW - Recovery
UR - http://www.scopus.com/inward/record.url?scp=85202466586&partnerID=8YFLogxK
U2 - 10.1007/s12028-024-02068-1
DO - 10.1007/s12028-024-02068-1
M3 - Article
C2 - 39143375
AN - SCOPUS:85202466586
SN - 1541-6933
VL - 41
SP - 357
EP - 368
JO - Neurocritical Care
JF - Neurocritical Care
IS - 2
ER -