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 (Preprint) Article Swipe
Rapheal Cinotti
,
Amandine Chenet
,
L. Oujamaa
,
Bertrand Glize
,
Yoann Launey
,
Yvan Derouin
,
Claire Dahyot‐Fizelier
,
Emmanuelle Cartron
,
Bénédicte Sautenet
,
Véronique Sébille
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.2196/preprints.54525
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.2196/preprints.54525
BACKGROUND : With more than 60 million new cases around the world each year, traumatic brain injury (TBI) causes substantial mortality and morbidity. Managing TBI is a major human, social, and economic concern. In the last 20 years, there has been an increase in clinical trials in neurocritical care, leading mostly to negative results. The evaluation of neurological outcomes, predominantly as primary outcomes, using clinical scales (Glasgow Outcome Scale) has limitations that could explain these results. Moreover, patient-centered outcomes are seldom reported despite their recognized clinical relevance. OBJECTIVE : The aim of this project is to establish a core outcome set (COS) for patients with moderate-to-severe TBI in randomized control trials in neurocritical care research. METHODS This study will follow five distinct steps: (1) systematic review to identify outcomes that have been reported in trials; (2) semistructured interviews with patients and their families to identify their priorities after TBI and explore potential patient-centered outcomes; (3) health care stakeholder focus groups with clinicians, researchers, and policy makers to describe potential outcomes; (4) an eDelphi survey with stakeholder groups to make a list of previously identified core outcomes; and (5) a consensus workshop to establish a COS for moderate-to-severe TBI clinical trials. RESULTS : The systematic review was published in August 2024. Regarding Step 2, 30 semistructured interviews of patients and relatives were performed from July 2021 to December 2023, and analyses were completed in October 2024. Step 3 is currently under development, and Step 4 is planned for the end of 2025. Step 5 is expected to occur during fall/winter 2026. Conclusions: Establishing a COS, to be consistently measured and reported in TBI trials in neurocritical care will ensure rigorous reporting, avoid bias, and improve the integrity, transparency, and usability of clinical research. The French context of the study is the main limitation, but we are seeking international collaboration on the project. The results of each step of the project will be disseminated through abstracts, publications, and patient associations. CONCLUSIONS Establishing a COS, to be consistently measured and reported in TBI trials in neurocritical care will ensure rigorous reporting, avoid bias, and improve the integrity, transparency, and usability of clinical research. The French context of the study is the main limitation, but we are seeking international collaboration on the project. The results of each step of the project will be disseminated through abstracts, publications, and patient associations. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/54525
Related Topics
Concepts
Glasgow Outcome Scale
Clinical trial
Medicine
Traumatic brain injury
Outcome (game theory)
Protocol (science)
Delphi method
Set (abstract data type)
Stakeholder
Psychiatry
Alternative medicine
Internal medicine
Pathology
Statistics
Public relations
Computer science
Mathematics
Mathematical economics
Programming language
Political science
Metadata
- Type
- preprint
- Language
- en
- Landing Page
- https://doi.org/10.2196/preprints.54525
- OA Status
- gold
- References
- 31
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4388694594
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4388694594Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.2196/preprints.54525Digital Object Identifier
- Title
-
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 (Preprint)Work title
- Type
-
preprintOpenAlex work type
- Language
-
enPrimary language
- Publication year
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2023Year of publication
- Publication date
-
2023-11-14Full publication date if available
- Authors
-
Rapheal Cinotti, Amandine Chenet, L. Oujamaa, Bertrand Glize, Yoann Launey, Yvan Derouin, Claire Dahyot‐Fizelier, Emmanuelle Cartron, Bénédicte Sautenet, Véronique SébilleList of authors in order
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https://doi.org/10.2196/preprints.54525Publisher landing page
- Open access
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
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https://doi.org/10.2196/preprints.54525Direct OA link when available
- Concepts
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Glasgow Outcome Scale, Clinical trial, Medicine, Traumatic brain injury, Outcome (game theory), Protocol (science), Delphi method, Set (abstract data type), Stakeholder, Psychiatry, Alternative medicine, Internal medicine, Pathology, Statistics, Public relations, Computer science, Mathematics, Mathematical economics, Programming language, Political scienceTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
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31Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.2024. | 216, 241 |
| abstract_inverted_index.2025. | 257 |
| abstract_inverted_index.2026. | 266 |
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| abstract_inverted_index.seldom | 81 |
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| abstract_inverted_index.trials | 46, 113, 279, 349 |
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| abstract_inverted_index.trials; | 139 |
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| abstract_inverted_index.identify | 132, 149 |
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| abstract_inverted_index.measured | 274, 344 |
| abstract_inverted_index.negative | 53 |
| abstract_inverted_index.outcomes | 79, 133 |
| abstract_inverted_index.patients | 106, 144, 224 |
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| abstract_inverted_index.reported | 82, 137, 276, 346 |
| abstract_inverted_index.results. | 54, 76 |
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| abstract_inverted_index.moderate-to-severe | 108, 201 |
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