Evidence map›Paper›PMID 36848418›Full record

ReviewStroke2023

Domain-Specific Outcome Measures in Clinical Trials of Therapies Promoting Stroke Recovery: A Suggested Blueprint.

Steven C Cramer, David J Lin, Seth P Finklestein

Abstract readReview
In one paragraph

Review in Stroke, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
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  11. Review
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

3 authors.

Steven C CramerDepartment of Neurology, University of California, Los Angeles; and California Rehabilitation Institute, Los Angeles (S.C.C.).ORCID 0000-0002-6214-6211
David J LinDepartment of Neurology, Stroke Service (D.J.L., S.P.F.), Massachusetts General Hospital, Harvard Medical School, Boston.ORCID 0000-0002-6575-9849
Seth P FinklesteinDepartment of Neurology, Stroke Service (D.J.L., S.P.F.), Massachusetts General Hospital, Harvard Medical School, Boston.ORCID 0000-0002-6682-3259

Funding

NSTN National Clinical Coordinating CenterU01NS086872 · NINDS · UNIVERSITY OF CINCINNATI · PI Joseph Paul Broderick, Pooja Khatri · 2013 to 2026
$32.3M
Validation of Early Prognostic Data for Recovery Outcomes after Stroke for Future, Higher Yield Trials (VERIFY)U01NS120910 · NINDS · YALE UNIVERSITY · PI Steven C. Cramer, Pooja Khatri · 2021 to 2026
$13.5M
Motor Recovery through Plasticity-Inducing Cortical StimulationUH3NS121565 · NINDS · UNIVERSITY OF WASHINGTON · PI Steven C. Cramer, Jeffrey G Ojemann · 2022 to 2026
$4.5M
Brain-computer interface-functional electrical stimulation for stroke recoveryR01HD095457 · NICHD · UNIVERSITY OF CALIFORNIA-IRVINE · PI CRAMER, STEVEN C., DO, AN · 2019 to 2023
$3.7M
EFFECTIVENESS OF ROBOT-ASSISTED HAND MOVEMENT TRAINING AFTER STROKER01HD062744 · NICHD · UNIVERSITY OF CALIFORNIA-IRVINE · PI David Jay Reinkensmeyer · 2010 to 2026
$3.5M
Supplement to Effects of global brain health on sensorimotor recovery after strokeR01NS115845 · NINDS · UNIVERSITY OF SOUTHERN CALIFORNIA · PI LIEW, SOOK-LEI · 2020 to 2024
$3.2M
NICHD NIH HHS R01 HD062744NICHD NIH HHS R01 HD095457NINDS NIH HHS R01 NS115845NINDS NIH HHS U01 NS086872NINDS NIH HHS U01 NS120910NINDS NIH HHS UH3 NS121565RRD VA IK1 RX003563
6 · The paper itself

Abstract

Different deficits recover to different degrees and with different time courses after stroke, indicating that plasticity differs across the brain's neural systems after stroke. To capture these differences, domain-specific outcome measures have received increased attention. Such measures have potential advantages over global outcome scales, which combine recovery across many domains into a single score and so blur the ability to capture individual measures of stroke recovery. Use of a global end point to rate disability can overlook substantial recovery in specific domains, such as motor or language, and may not differentiate between good and poor recovery for specific neurological domains. In light of these points, a blueprint is proposed for using domain-specific outcome measures in stroke recovery trials. Key steps include selecting a domain in the context of preclinical data, picking a domain-specific clinical trial end point, anchoring inclusion criteria to this end point, scoring this end point both before and after treatment, and then pursuing regulatory approval on the basis of the domain-specific results. This blueprint is intended to foster clinical trials that, by using domain-specific end points, are able to demonstrate favorable results in clinical trials of therapies that promote stroke recovery.

Indexed as

StrokeHumansLanguageclinical trialend point determinationneuronal plasticityrecovery of functionstroke

Identifiers

PMID36848418
PMCPMC9991075

What OpenQuestion holds

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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.