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 - Robertson, Courtney
AU - Muehlschlegel, Susanne
AU - Ling, Geoffrey
AU - Hanley, Daniel
AU - Farrokh, Salia
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
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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 -