Evidence map›Paper›PMID 39143375›Full record

ArticleNeurocritical care2024

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

Yelena G Bodien, Kerri LaRovere, Daniel Kondziella, Shaurya Taran, Anna Estraneo, Lori Shutter, Curing Coma Campaign, its Contributing Members

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In one paragraph

Article in Neurocritical care, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Observational
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Yelena G BodienDepartment of Neurology, Center for Neurotechnology and Neurorecovery, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. ybodien@mgh.harvard.edu.ORCID 0000-0003-4858-2903
Kerri LaRovereDepartment of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
Daniel KondziellaDepartment of Neurology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Shaurya TaranInterdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
Anna EstraneoDepartment of Neurorehabilitation, IRCCS, Don Carlo Gnocchi Foundation, Florence, Italy.
Lori ShutterDepartments of Critical Care Medicine, Neurology, and Neurosurgery, UPMC Healthcare System, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Curing Coma Campaign, its Contributing Members

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinical 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.

methodsThe 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.

resultsAmong 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.

conclusionsThe 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.

Indexed as

Common Data ElementsConsciousness DisordersOutcome Assessment, Health CareHumansNational Institute of Neurological Disorders and Stroke (U.S.)ComaCommon data elementsConsciousnessOutcomeRecovery

Identifiers

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.