Common Data Elements for Disorders of Consciousness: Recommendations from the Working Group on Outcomes and Endpoints

doi:10.1007/s12028-024-02068-1

. 2024 Oct;41(2):357-368.

doi: 10.1007/s12028-024-02068-1. Epub 2024 Aug 14.

Common Data Elements for Disorders of Consciousness: Recommendations from the Working Group on Outcomes and Endpoints

Yelena G Bodien^{1

2}, Kerri LaRovere³, Daniel Kondziella^{4

5}, Shaurya Taran⁶, Anna Estraneo⁷, Lori Shutter⁸; Curing Coma Campaign, its Contributing Members

Collaborators, Affiliations

Collaborators

Curing Coma Campaign, its Contributing Members:
Venkatesh Aiyagari, Yama Akbari, Fawaz Al-Mufti, Sheila Alexander, Anne Alexandrov, Ayham Alkhachroum, Moshagan Amiri, Brian Appavu, Meron Awraris Gebre, Mary Kay Bader, Neeraj Badjiata, Ram Balu, Megan Barra, Rachel Beekman, Ettore Beghi, Kathleen Bell, Erta Beqiri, Tracey Berlin, Thomas Bleck, Yelena Bodien, Varina Boerwinkle, Melanie Boly, Alexandra Bonnel, Emery Brown, Eder Caceres, Elizabeth Carroll, Emilio Cediel, Sherry Chou, Giuseppe Citerio, Jan Claassen, Chad Condie, Katie Cosmas, Claire Creutzfeldt, Neha Dangayach, Michael DeGeorgia, Caroline Der-Nigoghossian, Masoom Desai, Michael Diringer, James Dullaway, Brian Edlow, Ari Ercole, Anna Estraneo, Guido Falcone, Salia Farrokh, Simona Ferioli, Davinia Fernandez-Espejo, Ericka Fink, Joseph Fins, Brandon Foreman, Jennifer Frontera, Rishi Ganesan, Ahmeneh Ghavam, Joseph Giacino, Christie Gibbons, Emily Gilmore, Olivia Gosseries, Theresa Green, David Greer, Mary Guanci, Cecil Hahn, Ryan Hakimi, Flora Hammond, Daniel Hanley, Jed Hartings, Ahmed Hassan, Claude Hemphill, H E Hinson, Karen Hirsch, Sarah Hocker, Peter Hu, Xiao Hu, Theresa Human, David Hwang, Judy Illes, Matthew Jaffa, Michael L James, Anna Janas, Morgan Jones, Emanuela Keller, Maggie Keogh, Jenn Kim, Keri Kim, Hannah Kirsch, Matt Kirschen, Nerissa Ko, Daniel Kondziella, Natalie Kreitzer, Julie Kromm, Abhay Kumar, Pedro Kurtz, Steven Laureys, Thomas Lawson, Nicolas Lejeune, Ariane Lewis, John Liang, Geoffrey Ling, Sarah Livesay, Andrea Luppi, Lori Madden, Craig Maddux, Dea Mahanes, Shraddha Mainali, Nelson Maldonado, Rennan Martins Ribeiro, Marcello Massimini, Stephan Mayer, Victoria McCredie, Molly McNett, Jorge Mejia-Mantilla, David Menon, Geert Meyfroidt, Julio Mijangos, Dick Moberg, Asma Moheet, Erika Molteni, Martin Monti, Chris Morrison, Susanne Muehlschlegel, Brooke Murtaugh, Lionel Naccache, Masao Nagayama, Emerson Nairon, Girija Natarajan, Virginia Newcombe, Niklas Nielsen, Naomi Niznick, Filipa Noronha-Falcão, Paul Nyquist, DaiWai Olson, Marwan Othman, Adrian Owen, Llewellyn Padayachy, Soojin Park, Melissa Pergakis, Len Polizzotto, Nader Pouratian, Marilyn Price Spivack, Lara Prisco, Javier Provencio, Louis Puybasset, Chethan Rao, Lindsay Rasmussen, Verena Rass, Michael Reznik, Risa Richardson, Cassia Righy Shinotsuka, Cassia Righy Shinotsuka, Chiara Robba, Courtney Robertson, Benjamin Rohaut, John Rolston, Mario Rosanova, Eric Rosenthal, Mary Beth Russell, Gisele Sampaio Silva, Leandro Sanz, Simone Sarasso, Aarti Sarwal, Nicolas Schiff, Caroline Schnakers, David Seder, Vishank Shah, Amy Shapiro-Rosen, Angela Shapshak, Kartavya Sharma, Tarek Sharshar, Lori Shutter, Jacobo Sitt, Beth Slomine, Peter Smielewski, Wade Smith, Emmanuel Stamatakis, Alexis Steinberg, Robert Stevens, Jose Suarez, Bethany Sussman, Aurore Thibaut, Zachary Threlkeld, Lorenzo Tinti, Daniel Toker, Michel Torbey, Stephen Trevick, Alexis Turgeon, Andrew Udy, Panos Varelas, Paul Vespa, Walter Videtta, Henning Voss, Ford Vox, Amy Wagner, Mark Wainwright, John Whyte, Briana Witherspoon, Aleksandra Yakhind, Ross Zafonte, Darin Zahuranec, Chris Zammit, Bei Zhang, Wendy Ziai, Lara Zimmerman, Elizabeth Zink

Affiliations

¹ Department of Neurology, Center for Neurotechnology and Neurorecovery, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. ybodien@mgh.harvard.edu.
² Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Charlestown, MA, USA. ybodien@mgh.harvard.edu.
³ Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
⁴ Department of Neurology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
⁵ Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
⁶ Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
⁷ Department of Neurorehabilitation, IRCCS, Don Carlo Gnocchi Foundation, Florence, Italy.
⁸ Departments of Critical Care Medicine, Neurology, and Neurosurgery, UPMC Healthcare System, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.

PMID: 39143375
DOI: 10.1007/s12028-024-02068-1

Free article

Common Data Elements for Disorders of Consciousness: Recommendations from the Working Group on Outcomes and Endpoints

Yelena G Bodien et al. Neurocrit Care. 2024 Oct.

Free article

. 2024 Oct;41(2):357-368.

doi: 10.1007/s12028-024-02068-1. Epub 2024 Aug 14.

Authors

Yelena G Bodien^{1

2}, Kerri LaRovere³, Daniel Kondziella^{4

5}, Shaurya Taran⁶, Anna Estraneo⁷, Lori Shutter⁸; Curing Coma Campaign, its Contributing Members

Collaborators

Curing Coma Campaign, its Contributing Members:
Venkatesh Aiyagari, Yama Akbari, Fawaz Al-Mufti, Sheila Alexander, Anne Alexandrov, Ayham Alkhachroum, Moshagan Amiri, Brian Appavu, Meron Awraris Gebre, Mary Kay Bader, Neeraj Badjiata, Ram Balu, Megan Barra, Rachel Beekman, Ettore Beghi, Kathleen Bell, Erta Beqiri, Tracey Berlin, Thomas Bleck, Yelena Bodien, Varina Boerwinkle, Melanie Boly, Alexandra Bonnel, Emery Brown, Eder Caceres, Elizabeth Carroll, Emilio Cediel, Sherry Chou, Giuseppe Citerio, Jan Claassen, Chad Condie, Katie Cosmas, Claire Creutzfeldt, Neha Dangayach, Michael DeGeorgia, Caroline Der-Nigoghossian, Masoom Desai, Michael Diringer, James Dullaway, Brian Edlow, Ari Ercole, Anna Estraneo, Guido Falcone, Salia Farrokh, Simona Ferioli, Davinia Fernandez-Espejo, Ericka Fink, Joseph Fins, Brandon Foreman, Jennifer Frontera, Rishi Ganesan, Ahmeneh Ghavam, Joseph Giacino, Christie Gibbons, Emily Gilmore, Olivia Gosseries, Theresa Green, David Greer, Mary Guanci, Cecil Hahn, Ryan Hakimi, Flora Hammond, Daniel Hanley, Jed Hartings, Ahmed Hassan, Claude Hemphill, H E Hinson, Karen Hirsch, Sarah Hocker, Peter Hu, Xiao Hu, Theresa Human, David Hwang, Judy Illes, Matthew Jaffa, Michael L James, Anna Janas, Morgan Jones, Emanuela Keller, Maggie Keogh, Jenn Kim, Keri Kim, Hannah Kirsch, Matt Kirschen, Nerissa Ko, Daniel Kondziella, Natalie Kreitzer, Julie Kromm, Abhay Kumar, Pedro Kurtz, Steven Laureys, Thomas Lawson, Nicolas Lejeune, Ariane Lewis, John Liang, Geoffrey Ling, Sarah Livesay, Andrea Luppi, Lori Madden, Craig Maddux, Dea Mahanes, Shraddha Mainali, Nelson Maldonado, Rennan Martins Ribeiro, Marcello Massimini, Stephan Mayer, Victoria McCredie, Molly McNett, Jorge Mejia-Mantilla, David Menon, Geert Meyfroidt, Julio Mijangos, Dick Moberg, Asma Moheet, Erika Molteni, Martin Monti, Chris Morrison, Susanne Muehlschlegel, Brooke Murtaugh, Lionel Naccache, Masao Nagayama, Emerson Nairon, Girija Natarajan, Virginia Newcombe, Niklas Nielsen, Naomi Niznick, Filipa Noronha-Falcão, Paul Nyquist, DaiWai Olson, Marwan Othman, Adrian Owen, Llewellyn Padayachy, Soojin Park, Melissa Pergakis, Len Polizzotto, Nader Pouratian, Marilyn Price Spivack, Lara Prisco, Javier Provencio, Louis Puybasset, Chethan Rao, Lindsay Rasmussen, Verena Rass, Michael Reznik, Risa Richardson, Cassia Righy Shinotsuka, Cassia Righy Shinotsuka, Chiara Robba, Courtney Robertson, Benjamin Rohaut, John Rolston, Mario Rosanova, Eric Rosenthal, Mary Beth Russell, Gisele Sampaio Silva, Leandro Sanz, Simone Sarasso, Aarti Sarwal, Nicolas Schiff, Caroline Schnakers, David Seder, Vishank Shah, Amy Shapiro-Rosen, Angela Shapshak, Kartavya Sharma, Tarek Sharshar, Lori Shutter, Jacobo Sitt, Beth Slomine, Peter Smielewski, Wade Smith, Emmanuel Stamatakis, Alexis Steinberg, Robert Stevens, Jose Suarez, Bethany Sussman, Aurore Thibaut, Zachary Threlkeld, Lorenzo Tinti, Daniel Toker, Michel Torbey, Stephen Trevick, Alexis Turgeon, Andrew Udy, Panos Varelas, Paul Vespa, Walter Videtta, Henning Voss, Ford Vox, Amy Wagner, Mark Wainwright, John Whyte, Briana Witherspoon, Aleksandra Yakhind, Ross Zafonte, Darin Zahuranec, Chris Zammit, Bei Zhang, Wendy Ziai, Lara Zimmerman, Elizabeth Zink

Affiliations

¹ Department of Neurology, Center for Neurotechnology and Neurorecovery, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. ybodien@mgh.harvard.edu.
² Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Charlestown, MA, USA. ybodien@mgh.harvard.edu.
³ Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
⁴ Department of Neurology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
⁵ Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
⁶ Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
⁷ Department of Neurorehabilitation, IRCCS, Don Carlo Gnocchi Foundation, Florence, Italy.
⁸ Departments of Critical Care Medicine, Neurology, and Neurosurgery, UPMC Healthcare System, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.

PMID: 39143375
DOI: 10.1007/s12028-024-02068-1

Erratum in

Correction: Common Data Elements for Disorders of Consciousness: Recommendations from the Working Group on Outcomes and Endpoints.
Bodien YG, LaRovere K, Kondziella D, Taran S, Estraneo A, Shutter L; Curing Coma Campaign, its Contributing Members. Bodien YG, et al. Neurocrit Care. 2025 Feb;42(1):324. doi: 10.1007/s12028-024-02134-8. Neurocrit Care. 2025. PMID: 39304560 No abstract available.

Abstract

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.

Keywords: Coma; Common data elements; Consciousness; Outcome; Recovery.

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Cited by

Acute biomarkers of consciousness are associated with recovery after severe traumatic brain injury.
Bodien YG, Fecchio M, Gilmore N, Freeman HJ, Sanders WR, Meydan A, Lawrence PK, Atalay AS, Kirsch J, Healy BC, Edlow BL. Bodien YG, et al. medRxiv [Preprint]. 2025 Mar 5:2025.03.02.25322248. doi: 10.1101/2025.03.02.25322248. medRxiv. 2025. PMID: 40093212 Free PMC article. Preprint.

References

1. Bodien YG, McCrea M, Dikmen S, et al. Optimizing outcome assessment in multicenter TBI trials: perspectives from TRACK-TBI and the TBI endpoints development initiative. J Head Trauma Rehabil. 2018;33(3):147–57. - PubMed - PMC - DOI
1. Bodien YG, Barber J, Taylor SR, et al. Feasibility and utility of a Flexible Outcome Assessment battery for longitudinal traumatic brain injury research: a TRACK-TBI study. J Neurotrauma. 2023;40(3–4):337–48. - PubMed - PMC - DOI
1. Dams-O’Connor K, Gibbons LE, Bowen JD, et al. Risk for late-life re-injury, dementia and death among individuals with traumatic brain injury: a population-based study. J Neurol Neurosurg Psychiatry. 2013;84(2):177–82. - PubMed - DOI
1. Dams-O’Connor K, Ketchum JM, Cuthbert JP, et al. Functional outcome trajectories following inpatient rehabilitation for TBI in the United States: a NIDILRR TBIMS and CDC interagency collaboration. J Head Trauma Rehabil. 2020;35(2):127–39. - PubMed - PMC - DOI
1. Estraneo A, Moretta P, Loreto V, et al. Late recovery after traumatic, anoxic, or hemorrhagic long-lasting vegetative state. Neurology. 2010;75(3):239–45. - PubMed - DOI

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[1] Bodien YG, McCrea M, Dikmen S, et al. Optimizing outcome assessment in multicenter TBI trials: perspectives from TRACK-TBI and the TBI endpoints development initiative. J Head Trauma Rehabil. 2018;33(3):147–57. - PubMed - PMC - DOI

[2] Bodien YG, McCrea M, Dikmen S, et al. Optimizing outcome assessment in multicenter TBI trials: perspectives from TRACK-TBI and the TBI endpoints development initiative. J Head Trauma Rehabil. 2018;33(3):147–57. - PubMed - PMC - DOI

[3] Bodien YG, Barber J, Taylor SR, et al. Feasibility and utility of a Flexible Outcome Assessment battery for longitudinal traumatic brain injury research: a TRACK-TBI study. J Neurotrauma. 2023;40(3–4):337–48. - PubMed - PMC - DOI

[4] Bodien YG, Barber J, Taylor SR, et al. Feasibility and utility of a Flexible Outcome Assessment battery for longitudinal traumatic brain injury research: a TRACK-TBI study. J Neurotrauma. 2023;40(3–4):337–48. - PubMed - PMC - DOI

[5] Dams-O’Connor K, Gibbons LE, Bowen JD, et al. Risk for late-life re-injury, dementia and death among individuals with traumatic brain injury: a population-based study. J Neurol Neurosurg Psychiatry. 2013;84(2):177–82. - PubMed - DOI

[6] Dams-O’Connor K, Gibbons LE, Bowen JD, et al. Risk for late-life re-injury, dementia and death among individuals with traumatic brain injury: a population-based study. J Neurol Neurosurg Psychiatry. 2013;84(2):177–82. - PubMed - DOI

[7] Dams-O’Connor K, Ketchum JM, Cuthbert JP, et al. Functional outcome trajectories following inpatient rehabilitation for TBI in the United States: a NIDILRR TBIMS and CDC interagency collaboration. J Head Trauma Rehabil. 2020;35(2):127–39. - PubMed - PMC - DOI

[8] Dams-O’Connor K, Ketchum JM, Cuthbert JP, et al. Functional outcome trajectories following inpatient rehabilitation for TBI in the United States: a NIDILRR TBIMS and CDC interagency collaboration. J Head Trauma Rehabil. 2020;35(2):127–39. - PubMed - PMC - DOI

[9] Estraneo A, Moretta P, Loreto V, et al. Late recovery after traumatic, anoxic, or hemorrhagic long-lasting vegetative state. Neurology. 2010;75(3):239–45. - PubMed - DOI

[10] Estraneo A, Moretta P, Loreto V, et al. Late recovery after traumatic, anoxic, or hemorrhagic long-lasting vegetative state. Neurology. 2010;75(3):239–45. - PubMed - DOI

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Common Data Elements for Disorders of Consciousness: Recommendations from the Working Group on Outcomes and Endpoints

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Common Data Elements for Disorders of Consciousness: Recommendations from the Working Group on Outcomes and Endpoints

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