Evidence map›Paper›PMID 37535178›Full record

ReviewNeurocritical care2024

Optimal Design of Clinical Trials Involving Persons with Disorders of Consciousness.

Sung-Min Cho, Chiara Robba, Michael N Diringer, Daniel F Hanley, J Claude Hemphill, Janneke Horn, Ariane Lewis, Sarah L Livesay, David Menon, Tarek Sharshar and 8 more

Abstract readReview
PubMed Publisher
In one paragraph

Review in Neurocritical care, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Sung-Min Cho *Neuroscience Critical Care Division, Departments of Neurology, and Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, 600 N. Wolfe Street , Baltimore, MD, 21287, USA.
Chiara Robba *IRCCS for Oncology and Neuroscience and Department of Surgical Science and Integrated Diagnostic, San Martino Policlinico Hospital, University of Genoa, Genoa, Italy.
Michael N DiringerDepartments of Neurology, Washington University in St. Louis, St. Louis, MO, USA.
Daniel F HanleyNeuroscience Critical Care Division, Departments of Neurology, and Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, 600 N. Wolfe Street , Baltimore, MD, 21287, USA.
J Claude HemphillWeill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, USA.
Janneke HornUniversity of Amsterdam, Amsterdam, Netherlands.
Ariane LewisDivision of Neurocritical Care, Department of Neurology and Neurosurgery, New York University, New York, NY, USA.
Sarah L LivesayDepartment of Adult Health and Gerontological Nursing, College of Nursing, Rush University, Chicago, IL, USA.
David MenonDepartment of Medicine, University of Cambridge, Cambridge, UK.
Tarek SharsharDepartments of Neurology and Intensive Care Medicine, Paris-Descartes University, Paris, France.
Robert D StevensNeuroscience Critical Care Division, Departments of Neurology, and Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, 600 N. Wolfe Street , Baltimore, MD, 21287, USA.
James TornerDepartment of Epidemiology, University of Iowa, Iowa City, IA, USA.
Paul M VespaDepartments of Neurology and Neurosurgery, University of California, Los Angeles, Los Angeles, CA, USA.
Wendy C ZiaiNeuroscience Critical Care Division, Departments of Neurology, and Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, 600 N. Wolfe Street , Baltimore, MD, 21287, USA.
Marcus SpannNeuroscience Critical Care Division, Departments of Neurology, and Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, 600 N. Wolfe Street , Baltimore, MD, 21287, USA.
Raimund HelbokDepartments of Neurology and Medicine, Innsbruck Medical University, Innsbruck, Austria.
Jose I SuarezNeuroscience Critical Care Division, Departments of Neurology, and Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, 600 N. Wolfe Street , Baltimore, MD, 21287, USA. jsuarez5@jhmi.edu.ORCID 0000-0003-0548-9936
Curing Coma Campaign and its contributing members

Funding

CLots and Oxygen in Va-ExtracorpoReal membrane oxygenation (CLOVER) studyK23HL157610 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI Sung-Min Cho · 2022 to 2026
$797k
NHLBI NIH HHS K23 HL157610
6 · The paper itself

Abstract

backgroundLimited data exist regarding the optimal clinical trial design for studies involving persons with disorders of consciousness (DoC), and only a few therapies have been tested in high-quality clinical trials. To address this, the Curing Coma Campaign Clinical Trial Working Group performed a gap analysis on the current state of clinical trials in DoC to identify the optimal clinical design for studies involving persons with DoC.

methodsThe Curing Coma Campaign Clinical Trial Working Group was divided into three subgroups to (1) review clinical trials involving persons with DoC, (2) identify unique challenges in the design of clinical trials involving persons with DoC, and (3) recommend optimal clinical trial designs for DoC.

resultsThere were 3055 studies screened, and 66 were included in this review. Several knowledge gaps and unique challenges were identified. There is a lack of high-quality clinical trials, and most data regarding patients with DoC are based on observational studies focusing on patients with traumatic brain injury and cardiac arrest. There is a lack of a structured long-term outcome assessment with significant heterogeneity in the methodology, definitions of outcomes, and conduct of studies, especially for long-term follow-up. Another major barrier to conducting clinical trials is the lack of resources, especially in low-income countries. Based on the available data, we recommend incorporating trial designs that use master protocols, sequential multiple assessment randomized trials, and comparative effectiveness research. Adaptive platform trials using a multiarm, multistage approach offer substantial advantages and should make use of biomarkers to assess treatment responses to increase trial efficiency. Finally, sound infrastructure and international collaboration are essential to facilitate the conduct of trials in patients with DoC.

conclusionsConduct of trials in patients with DoC should make use of master protocols and adaptive design and establish international registries incorporating standardized assessment tools. This will allow the establishment of evidence-based practice recommendations and decrease variations in care.

Indexed as

Brain Injuries, TraumaticConsciousness DisordersAdaptive Clinical Trials as TopicComaHumansOutcome Assessment, Health CareResearch DesignAltered consciousnessClinical trialsComaDisorders of consciousnessInterventionOutcome

Identifiers

PMID37535178

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.