Which version of the modified Rankin Scale should we use for stroke trials?

Maguire, Jane; Attia, John

doi:10.1212/wnl.0000000000006533

Cited by 3 publications

(2 citation statements)

References 7 publications

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“…However, analyses of trials using such dichotomous approaches could result in a loss of information and a risk of ignoring bi-directional effects, and they often require larger samples than ordinal approaches [132][133][134]. Despite these pitfalls of dichotomization, ordinal analyses continue to be poorly adopted [135,136], and dichotomous approaches continue to be favored as the primary outcome by many high-profile trials [137,138]. One reason for this may be the poor clinical interpretability of conventional ordinal approaches, which provide outputs, like p-values or standard odds ratios, without intuitive effect sizes [139].…”

Section: Results In Contextmentioning

confidence: 99%

Sex-Related Differences in Mortality, Delayed Cerebral Ischemia, and Functional Outcomes in Patients with Aneurysmal Subarachnoid Hemorrhage: A Systematic Review and Meta-Analysis

Berli,

Barbagallo,

Keller

et al. 2024

JCM

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Background/Objective: Sex-related differences among patients with aneurysmal subarachnoid hemorrhage (aSAH) and their potential clinical implications have been insufficiently investigated. To address this knowledge gap, we conduct a comprehensive systematic review and meta-analysis. Methods: Sex-specific differences in patients with aSAH, including mortality, delayed cerebral ischemia (DCI), and functional outcomes were assessed. The functional outcome was dichotomized into favorable or unfavorable based on the modified Rankin Scale (mRS), Glasgow Outcome Scale (GOS), and Glasgow Outcome Scale Extended (GOSE). Results: Overall, 2823 studies were identified in EMBASE, MEDLINE, PubMed, and by manual search on 14 February 2024. After an initial assessment, 74 studies were included in the meta-analysis. In the analysis of mortality, including 18,534 aSAH patients, no statistically significant differences could be detected (risk ratio (RR) 0.99; 95% CI, 0.90–1.09; p = 0.91). In contrast, the risk analysis for DCI, including 23,864 aSAH patients, showed an 11% relative risk reduction in DCI in males versus females (RR, 0.89; 95% CI, 0.81–0.97; p = 0.01). The functional outcome analysis (favorable vs. unfavorable), including 7739 aSAH patients, showed a tendency towards better functional outcomes in men than women; however, this did not reach statistical significance (RR, 1.02; 95% CI, 0.98–1.07; p = 0.34). Conclusions: In conclusion, the available data suggest that sex/gender may play a significant role in the risk of DCI in patients with aSAH, emphasizing the need for sex-specific management strategies.

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Section: Results In Contextmentioning

confidence: 99%

Sex-Related Differences in Mortality, Delayed Cerebral Ischemia, and Functional Outcomes in Patients with Aneurysmal Subarachnoid Hemorrhage: A Systematic Review and Meta-Analysis

Berli,

Barbagallo,

Keller

et al. 2024

JCM

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“…Despite these pitfalls of dichotomization, adoption of ordinal analyses remains poor [7,8]. Although there has been a trend in recent years towards the use of ordinal analyses, dichotomous approaches continue to be favoured as the primary outcome by many high-profile trials [9,10].…”

Section: Introductionmentioning

confidence: 99%

Weights for ordinal analyses of the modified Rankin Scale in stroke trials: A population-based cohort study

et al. 2020

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Background: Ordinal/shift analyses of ordered measures like the modified Rankin Scale(mRS) are underused as primary trial outcomes for neurological disorders À despite statistical advantages À potentially hindered by poor clinical interpretability versus dichotomies, and by valuing state-transitions equally (linear scale). Weighted ordinal analyses incorporating step-changes at key transitions might have greater statistical validity and clinical applicability. Methods: In a prospective population-based cohort of ischaemic stroke (Oxford Vascular Study, recruited 2002-2014, we stratified 5-year outcomes of death, dementia, and/or institutionalization, health/social-care costs, and EuroQol-derived quality-adjusted life-expectancy(QALE) by 3-month mRS. We compared root-mean-square errors(RMSEs) from linear regressions for these outcomes with the mRS coded as a linear scale versus incorporating a spline at transitions 1-2, 2-3, or 3-4. We derived 3-month mRS weights for probability of 5-year death/ dementia/institutionalization using age/sex-adjusted logistic regressions, and cost and QALE weights from 1000bootstraps. We applied these weights to analyse recent trials of thrombectomy for acute ischaemic stroke. Findings: Among 1,607 patients, a non-linear (S-shaped) relationship was observed between 3-month mRS and each 5-year outcome, with RMSEs 18-73% lower using a spline at mRS 2-3 versus a linear representation. Age/ sex-adjusted probability weights for 5-year death/dementia/institutionalization were: mRS 0=0.19; 1=0.27; 2=0.41; 3=0.73; 4=0.77; 5=0.94 (mRS 6=1 by definition). Similar trends were seen with costs; estimated 5-year QALEs were: mRS 0=3.88; 1=3.49; 2=3.01; 3=1.87; 4=1.30; 5=0.06; 6=0. Results were similar stratifying by age/ sex, and excluding pre-morbidly disabled patients. Using a weighted ordinal approach, estimates of thrombectomy impact were more favourable than estimates with dichotomous approaches, 5-year cost reductions being 29% higher than with 0-2/3-6, and over three-fold higher than with 0-1/2-6 dichotomy. Interpretation: Our findings favour weighting the mRS in ordinal analyses for stroke and other neurological disorders, as state-transitions differ in clinical prognosis, quality-of-life, and costs. These weights could also be used for prognostication and cost-effectiveness analyses.

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Drug delivery pathways to the central nervous system via the brain glymphatic system circumventing the blood‐brain barrier

Wang,

Yin,

Zhou

et al. 2024

Exploration

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The blood‐brain barrier (BBB) poses daunting challenges in treating diseases associated with the central nervous system (CNS). Recently, the traditional notion of the absence of the lymphatic system in the brain is evolving. The discovery of the glymphatic system in the brain has stimulated tremendous interest in developing new strategies for the treatment of CNS diseases. Leveraging the glymphatic system for CNS drug delivery may pave a new avenue to circumvent the BBB and achieve efficient drug delivery. The review focuses on the glymphatic system of the brain, discussing potential factors affecting its functions and exploring their connections with the meningeal lymphatic system. Finally, the review provides an overview of the drug delivery methods through the glymphatic system to circumvent BBB and regulate brain immunity. These innovative drug delivery methods may significantly improve drug utilization and create new avenues for the treatment of brain diseases.

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Which version of the modified Rankin Scale should we use for stroke trials?

Cited by 3 publications

References 7 publications

Sex-Related Differences in Mortality, Delayed Cerebral Ischemia, and Functional Outcomes in Patients with Aneurysmal Subarachnoid Hemorrhage: A Systematic Review and Meta-Analysis

Sex-Related Differences in Mortality, Delayed Cerebral Ischemia, and Functional Outcomes in Patients with Aneurysmal Subarachnoid Hemorrhage: A Systematic Review and Meta-Analysis

Weights for ordinal analyses of the modified Rankin Scale in stroke trials: A population-based cohort study

Drug delivery pathways to the central nervous system via the brain glymphatic system circumventing the blood‐brain barrier

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