Abstract WP332: Updating the Structure of Stroke Clinical Research Data: Version 2 of the Stroke Common Data Elements From the National Institutes of Health/National Institute of Neurological Disorders and Stroke

Esterlitz, Joy; Saver, Jeffrey L.; Warach, Steven; Brott, Thomas G.; Sacco, Ralph L.; Sheikh, Muniza; Ala'i, Sherita; Odenkirchen, Joanne

doi:10.1161/str.47.suppl_1.wp332

Cited by 4 publications

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“…The primary efficacy end point was recurrent ischemic stroke: an acute neurologic deficit, presumed to be due to focal ischemia, and either symptoms persisting 24 hours or longer or symptoms persisting less than 24 hours but associated with neuroimaging findings of a new neuroanatomically relevant infarct. 26,27 The secondary efficacy outcomes were (1) recurrent PFOassociated ischemic stroke (recurrent ischemic strokes adjudicated as not being attributable to another mechanism by investigators of the individual trials); (2) the composite of recurrent ischemic stroke or early (periprocedural or equivalent medical therapy time frame) all-cause mortality; (3) the composite of recurrent ischemic stroke, early all-cause mortality, or any vascular death; (4) the composite of recurrent ischemic stroke, transient ischemic attack (TIA), or vascular death; (5) disability-worsening recurrent ischemic stroke; and (6) any recurrent stroke (ischemic or hemorrhagic).…”

Section: Discussionmentioning

confidence: 99%

Heterogeneity of Treatment Effects in an Analysis of Pooled Individual Patient Data From Randomized Trials of Device Closure of Patent Foramen Ovale After Stroke

Kent

Saver

Kasner

et al. 2021

JAMA

123

139

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IMPORTANCEPatent foramen ovale (PFO)-associated strokes comprise approximately 10% of ischemic strokes in adults aged 18 to 60 years. While device closure decreases stroke recurrence risk overall, the best treatment for any individual is often unclear.OBJECTIVE To evaluate heterogeneity of treatment effect of PFO closure on stroke recurrence based on previously developed scoring systems.DESIGN, SETTING, AND PARTICIPANTS Investigators for the Systematic, Collaborative, PFO Closure Evaluation (SCOPE) Consortium pooled individual patient data from all 6 randomized clinical trials that compared PFO closure plus medical therapy vs medical therapy alone in patients with PFO-associated stroke, and included a total of 3740 participants. The trials were conducted worldwide from 2000 to 2017.EXPOSURES PFO closure plus medical therapy vs medical therapy alone. Subgroup analyses used the Risk of Paradoxical Embolism (RoPE) Score (a 10-point scoring system in which higher scores reflect younger age and the absence of vascular risk factors) and the PFO-Associated Stroke Causal Likelihood (PASCAL) Classification System, which combines the RoPE Score with high-risk PFO features (either an atrial septal aneurysm or a large-sized shunt) to classify patients into 3 categories of causal relatedness: unlikely, possible, and probable. MAIN OUTCOMES AND MEASURES Ischemic stroke.RESULTS Over a median follow-up of 57 months (IQR, 24-64), 121 outcomes occurred in 3740 patients. The annualized incidence of stroke with medical therapy was 1.09% (95% CI, 0.88%-1.36%) and with device closure was 0.47% (95% CI, 0.35%-0.65%) (adjusted hazard ratio [HR], 0.41 [95% CI, 0.28-0.60]). The subgroup analyses showed statistically significant interaction effects. Patients with low vs high RoPE Score had HRs of 0.61 (95% CI, 0.37-1.00) and 0.21 (95% CI, 0.11-0.42), respectively (P for interaction = .02). Patients classified as unlikely, possible, and probable using the PASCAL Classification System had HRs of 1.14 (95% CI, 0.53-2.46), 0.38 (95% CI, 0.22-0.65), and 0.10 (95% CI, 0.03-0.35), respectively (P for interaction = .003). The 2-year absolute risk reduction was −0.7% (95% CI, −4.0% to 2.6%), 2.1% (95% CI, 0.6%-3.6%), and 2.1% (95% CI, 0.9%-3.4%) in the unlikely, possible, and probable PASCAL categories, respectively. Device-associated adverse events were generally higher among patients classified as unlikely; the absolute risk increases in atrial fibrillation beyond day 45 after randomization with a device were 4.41% (95% CI, 1.02% to 7.80%), 1.53% (95% CI, 0.33% to 2.72%), and 0.65% (95% CI, −0.41% to 1.71%) in the unlikely, possible, and probable PASCAL categories, respectively.CONCLUSIONS AND RELEVANCE Among patients aged 18 to 60 years with PFO-associated stroke, risk reduction for recurrent stroke with device closure varied across groups classified by their probabilities that the stroke was causally related to the PFO. Application of this classification system has the potential to guide individualized decision-making.

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Section: Discussionmentioning

confidence: 99%

Heterogeneity of Treatment Effects in an Analysis of Pooled Individual Patient Data From Randomized Trials of Device Closure of Patent Foramen Ovale After Stroke

Kent

Saver

Kasner

et al. 2021

JAMA

123

139

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“…Perinatal intracerebral hemorrhage is defined within the National Institutes of Health Common Data Elements as a term neonate with encephalopathy, seizures, altered mental status, and/or neurological deficit within the first 28 days of life with a focal collection of blood within the brain parenchyma confirmed by neuroimaging or autopsy. 2 This is distinct from intracranial hemorrhage in preterm infants, where germinal matrix hemorrhages are common. 3 The definition does not address overlapping hemorrhages (intraventricular and subarachnoid), does not capture nongerminal matrix hemorrhages in the fetus, and excludes presentation beyond the neonatal period.…”

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confidence: 99%

Clinical Characteristics, Risk Factors, and Outcomes Associated With Neonatal Hemorrhagic Stroke

et al. 2017

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IMPORTANCE Hemorrhage into the brain of term newborns often results in major injury and lifelong disability. The clinical epidemiology of neonatal hemorrhagic stroke (NHS) remains undefined, hindering the development of strategies to improve outcomes.OBJECTIVE To characterize the incidence, types, presentations, associated factors, and outcomes of neonatal hemorrhagic stroke. DESIGN, SETTING, AND PARTICIPANTS Population-based, nested case-control study. The Alberta Perinatal Stroke Project, a provincial registry, ascertained NHS cases using exhaustive diagnostic code searching (1992-2010, >2500 medical record reviews). Prospective cases were captured through the Calgary Pediatric Stroke Program (2007)(2008)(2009)(2010)(2011)(2012)(2013)(2014). Participants included term neonates with magnetic resonance imaging-confirmed NHS including primary and secondary intracerebral hemorrhage, hemorrhagic transformation of ischemic injury, and presumed perinatal hemorrhagic stroke. Control infants with common data were recruited from a population-based study (4 to 1 ratio). MAIN OUTCOMES AND MEASURESInfants with NHS underwent structured medical record review using data-capture forms and blinded scoring of neuroimaging. Clinical risk factor common data elements were explored using logistic regression. Provincial live births were obtained from Statistics Canada. Outcomes were extrapolated to the Pediatric Stroke Outcome Measure. RESULTSWe identified 86 cases: 51 infants (59%) with NHS, of which 32 (67%) were idiopathic, 30 (35%) were hemorrhagic transformation of primary ischemic injuries (14 with neonatal cerebral sinovenous thrombosis, 11 with hypoxic ischemic encephalopathy, and 5 with neonatal arterial ischemic stroke), and 5 were presumed perinatal hemorrhagic stroke. Sixty-two percent were male. Incidence of pure NHS was 1 in 9500 live births and 1 in 6300 for all forms. Most presented in the first week of life with seizures and encephalopathy. Acute neurosurgical intervention was rare (3 of 86 total cases; 3.5%). Temporal lobe was the most common NHS location (16 of 51 pure NHS cases; 31%). A primary cause was evident in 19 of the 51 cases of non-hemorrhagic transformation NHS (37%). Idiopathic NHS was independently associated with lower maternal age (odds ratio [OR], 0.87; 95% CI, 0.78-0.94), primiparity (OR, 2.98; 95% CI, 1.18-7.50), prior spontaneous abortion (OR, 0.11; 95% CI, 0.02-0.53), difficult fetal transition (bradycardia [OR, 15.0; 95% CI,] and low Apgar [OR, 14.3; 95% CI, 2.77-73.5]), and small for gestational age (OR, 14.3; 95% CI, 1.62-126.1). Follow-up of 50 cases at a median of 37 months demonstrated poor neurological outcomes in 21 patients (44%). CONCLUSIONS AND RELEVANCENeonatal hemorrhagic stroke is more common than previously reported, occurring in at least 1 in 6300 live births. Etiologies are approximately equally distributed between idiopathic, secondary, and hemorrhagic transformation. Clinical associations do not suggest a common mechanism or predictability of NHS. Recurrence is rare. Outcomes a...

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“…As agreed across all Working Groups of the Curing Coma Campaign CDE initiative, new CDEs were assigned, by consensus opinion within each WG, to one of four categories, in line with the previous NINDS CDE initiatives [13][14][15][16][17]. The designation of "disease core" was used to indicate CDEs which are required to be collected for all DoC studies.…”

Section: Cde Classi Cationmentioning

confidence: 99%

“…Despite vigorous research, there is a notable absence of well-de ned common data elements (CDE) for DoC [12], unlike interventions in other elds such as stroke, traumatic brain injury, and subarachnoid hemorrhage, among others [13][14][15][16][17].…”

Section: Introductionmentioning

confidence: 99%

Common Data Element for Disorders of Consciousness: Recommendations from the Working Group on Therapeutic Interventions

Monti,

Beekman,

Spivak

et al. 2023

Neurocrit Care

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Background. Over the past thirty years, there have been signi cant advances in the understanding of the mechanisms associated with loss and recovery of consciousness following severe brain injury. This work has provided a strong grounding for the development of novel restorative therapeutic interventions. While all interventions are aimed at modulating, and thereby restoring, brain function, the landscape of existing interventions encompasses a very wide scope of techniques and protocols. Despite vigorous research efforts, few approaches have been assessed with rigorous, high-quality, randomized controlled trials. As a growing number of exploratory interventions emerge, it is paramount to develop standardized approaches to reporting results. The successful evaluation of novel interventions depends on implementation of shared nomenclature and infrastructure. To address this gap, the Neurocritical Care Society's Curing Coma Campaign convened nine working groups and charged them with developing Common Data Elements (CDEs). Here, we report the work of the Therapeutic Interventions Working Group. Methods. The Working Group reviewed existing CDEs relevant to therapeutic interventions within the NIH National Institute of Neurological Disorders and Stroke (NINDS) database and reviewed the literature for assessing key areas of research in the intervention space. CDEs were then proposed, iteratively discussed and reviewed, classi ed, and organized in a Case Report Form. Results. We developed a uni ed CRF, including CDEs and key design elements (KDE; i.e., methodological or protocol parameters), divided into ve sections: (i) patient information; (ii) general study information; (iii) behavioral interventions; (iv) pharmacological interventions; and (v) device interventions. Conclusion. The newly created CRF enhances systematization of future work by proposing a portfolio of measures that should be collected in the development and implementation of studies assessing novel interventions intended to increase the level of consciousness or rate of recovery of consciousness in patients with DoC

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Abstract WP332: Updating the Structure of Stroke Clinical Research Data: Version 2 of the Stroke Common Data Elements From the National Institutes of Health/National Institute of Neurological Disorders and Stroke

Cited by 4 publications

References 0 publications

Heterogeneity of Treatment Effects in an Analysis of Pooled Individual Patient Data From Randomized Trials of Device Closure of Patent Foramen Ovale After Stroke

Heterogeneity of Treatment Effects in an Analysis of Pooled Individual Patient Data From Randomized Trials of Device Closure of Patent Foramen Ovale After Stroke

Clinical Characteristics, Risk Factors, and Outcomes Associated With Neonatal Hemorrhagic Stroke

Common Data Element for Disorders of Consciousness: Recommendations from the Working Group on Therapeutic Interventions

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