Corrigendum: Staged use of ordinal and linear disability scales: a practical approach to granular assessment of acute stroke outcome.

[This corrects the article DOI: 10.3389/fneur.2023.1174686.].

Staged use of ordinal and linear disability scales: a practical approach to granular assessment of acute stroke outcome.

Background: The modified Rankin Scale (mRS) assessment of global disability is the most common primary endpoint in acute stroke trials but lacks granularity (7 broad levels) and is ordinal (scale levels unknown distances apart), which constrains study power. Disability scales that are linear and continuous may better discriminate outcomes, but computerized administration in stroke patients is challenging. We, therefore, undertook to develop a staged use of an ordinal followed by a linear scale practical to use in multicenter trials. Methods: Consecutive patients undergoing 3-month final visits in the NIH FAST-MAG phase 3 trial were assessed with the mRS followed by 15 mRS level-specific yes-no items of the Academic Medical Center Linear Disability Score (ALDS), a linear disability scale derived using item response theory. Results: Among 55 patients, aged 71.2 (SD ± 14.2), 67% were men and the entry NIHSS was 10.7 (SD ± 9.5). At 90 days, the median mRS score was 3 (IQR, 1-4), and the median ALDS score was 78.8 (IQR, 3.3-100). ALDS scores correlated strongly with 90 days outcome measures, including the Barthel Index (r = 0.92), NIHSS (r = 0.87), and mRS (r = 0.94). ALDS scores also correlated modestly with entry NIHSS (r = 0.38). At 90 days, the ALDS showed greater scale granularity than the mRS, with fewer patients with identical values, 1.9 (SD ± 3.2) vs. 8.0 (SD ± 3.6), p < 0.001. When treatment effect magnitudes were small to moderate, projected trial sample size requirements were 2-12-fold lower when the ALDS rather than the mRS was used as the primary trial endpoint. Conclusion: Among patients enrolled in an acute neuroprotective stroke trial, the ALDS showed strong convergent validity and superior discrimination characteristics compared with the modified Rankin Scale and increased projected trial power to detect clinically meaningful treatment benefits.

National Institutes of Health Stroke Scale Correlates Well with Initial Intracerebral Hemorrhage Volume.

OBJECTIVES: The US Centers for Medicare and Medicaid Services (CMS) currently publicly reports hospital-quality, risk-adjusted mortality measure for ischemic stroke but not intracerebral hemorrhage (ICH). The NIHSS, which is captured in CMS administrative claims data, is a candidate metric for use in ICH risk adjustment and has been shown to predict clinical outcome with accuracy similar to the ICH Score. Correlation between early NIHSS and initial ICH volume would further support use of the NIHSS for ICH risk adjustment. MATERIALS AND METHODS: Among 372 ICH patients enrolled in a large multicenter trial (FAST-MAG), the relation between early NIHSS and early ICH volume was assessed with correlation and linear trend analysis. RESULTS: Overall, there was strong correlation between NIHSS and ICH volume, r = 0.77 (p < 0.001), and for every 10cc increase in ICH the NIHSS increased by 4.5 points. Correlation coefficients were comparable in all subgroups, but magnitude of NIHSS increase with ICH unit volume increase was greater with left than right hemispheric ICH, with presence rather than absence of IVH, with imaging done within the first hour than second hour after last known well, with men than women, and with younger than older patients. CONCLUSION: Early NIHSS neurologic deficit severity values correlate strongly with initial ICH hematoma volume. As with ischemic stroke, lesion volume increases produce greater NIHSS change in the left than right hemisphere, reflecting greater NIHSS sensitivity to left hemisphere function. These findings provide further support for the use of NIHSS in risk-adjusted mortality measures for intracerebral hemorrhage.

Field Validation of the Los Angeles Motor Scale as a Tool for Paramedic Assessment of Stroke Severity.

BACKGROUND AND PURPOSE: The Los Angeles Motor Scale (LAMS) is a 3-item, 0- to 10-point motor stroke-deficit scale developed for prehospital use. We assessed the convergent, divergent, and predictive validity of the LAMS when performed by paramedics in the field at multiple sites in a large and diverse geographic region. METHODS: We analyzed early assessment and outcome data prospectively gathered in the FAST-MAG trial (Field Administration of Stroke Therapy-Magnesium phase 3) among patients with acute cerebrovascular disease (cerebral ischemia and intracranial hemorrhage) within 2 hours of onset, transported by 315 ambulances to 60 receiving hospitals. RESULTS: Among 1632 acute cerebrovascular disease patients (age 70±13 years, male 57.5%), time from onset to prehospital LAMS was median 30 minutes (interquartile range 20-50), onset to early postarrival (EPA) LAMS was 145 minutes (interquartile range 119-180), and onset to EPA National Institutes of Health Stroke Scale was 150 minutes (interquartile range 120-180). Between the prehospital and EPA assessments, LAMS scores were stable in 40.5%, improved in 37.6%, and worsened in 21.9%. In tests of convergent validity, against the EPA National Institutes of Health Stroke Scale, correlations were r=0.49 for the prehospital LAMS and r=0.89 for the EPA LAMS. Prehospital LAMS scores did diverge from the prehospital Glasgow Coma Scale, r=-0.22. Predictive accuracy (adjusted C statistics) for nondisabled 3-month outcome was as follows: prehospital LAMS, 0.76 (95% confidence interval 0.74-0.78); EPA LAMS, 0.85 (95% confidence interval 0.83-0.87); and EPA National Institutes of Health Stroke Scale, 0.87 (95% confidence interval 0.85-0.88). CONCLUSIONS: In this multicenter, prospective, prehospital study, the LAMS showed good to excellent convergent, divergent, and predictive validity, further establishing it as a validated instrument to characterize stroke severity in the field.

The Rankin Focused Assessment-Ambulation: A Method to Score the Modified Rankin Scale with Emphasis on Walking Ability.

BACKGROUND: In the assessment of poststroke functional outcome, there are 2 alternative approaches to rating patient independence in motion: (1) focusing solely on patient ambulation (discounting self-use of wheelchair) and (2) focusing broadly on patient mobility (counting self-use of wheelchair). This study was undertaken to create and assess the inter-rater reliability of a version of the Rankin Focused Assessment (RFA) that focuses on ambulation (Rankin Focused Assessment-Ambulation [RFA-A]), as an alternative to the original RFA that focused on mobility (Rankin Focused Assessment-Mobility [RFA-M]). METHODS: The RFA-A was created by changing instructions in the RFA-M for handling of nonambulatory, wheelchair-using patients. Paired study coordinators then applied the RFA-A to 50 consecutive patients enrolled in a phase 3 acute stroke trial. RESULTS: Among the 50 patients, the mean age was 72 years (range 43-93) and 48% were female. Overall, study coordinator pairs assigned the same modified Rankin Scale (mRS) grades to 48 of the 50 patients, yielding a weighted κ of .98 (95% confidence interval [CI] .96-1.00) and an unweighted κ of .95 (95% CI .89-1.02). At day 90, 43 patients were alive and 7 had died. Among surviving patients, the weighted κ was .98 (95% CI .95-1.00) and the unweighted κ was .94 (95% CI .86-1.02). The κ values for all 6 dichotomizations of the mRS score ranged from .93 to 1.00. CONCLUSIONS: The RFA-A demonstrates high inter-rater reliability in grading global functional outcome. The RFA-A is a useful tool for assigning an mRS score in research and clinical practice when functional assessment focused on ambulation is desired.

Funding mechanisms for gender-specific research: proceedings from a panel discussion at the 2014 Academic Emergency Medicine consensus conference.

As part of the 2014 Academic Emergency Medicine (AEM) consensus conference "Gender-Specific Research in Emergency Care: Investigate, Understand, and Translate How Gender Affects Patient Outcomes," we assembled a diverse panel of representatives from federal and nonfederal funding agencies to discuss future opportunities for sex- and gender-specific research. The discussion revolved around the mission and priorities of each organization, as well as its interest in promoting sex- and gender-specific research. The panelists were asked to provide specific examples of funding lines generated or planned for as pertinent to emergency care. Training opportunities for future researchers in this area were also discussed.

Improving the reliability of stroke disability grading in clinical trials and clinical practice: the Rankin Focused Assessment (RFA).

BACKGROUND AND PURPOSE: The modified Rankin Scale rates global disability after stroke and is the most comprehensive and widely used primary outcome measure in acute stroke trials. However, substantial interobserver variability in modified Rankin Scale scoring has been reported. This study sought to develop and validate a short, practicable structured assessment that would enhance interrater reliability. METHODS: The Rankin Focused Assessment was developed by selecting and refining elements from prior instruments. The Rankin Focused Assessment takes 3 to 5 minutes to apply and provides clear, operationalized criteria to distinguish the 7 assignable global disability levels. The Rankin Focused Assessment was prospectively validated 3 months poststroke among 50 consecutive patients enrolled in the Phase 3 National Institutes of Health Field Administration of Stroke Therapy-Magnesium (FAST-MAG) Trial. RESULTS: Among the 50 patients, mean age was 71.5 years (range, 43 to 93 years), 48% were female, and stroke subtype was hemorrhagic in 24%. At Day 90, 43 patients were alive and 7 had died. The modified Rankin Scale median was 2.0 and mean was 2.8. When pairs of 14 raters assessed all enrolled patients, the percent agreement was 94%, the weighted kappa was 0.99 (95% CI, 0.99 to 1.0), and the unweighted kappa was 0.93 (95% CI, 0.85 to 1.00). Among the 43 surviving patients, the percent agreement was 93%, the weighted kappa was 0.99 (0.98 to 1.0), and the unweighted kappa was 0.91 (0.82 to 1.00). CONCLUSIONS: The Rankin Focused Assessment yields high interrater reliability in the grading of final global disability among consecutive patients with stroke participating in a randomized clinical trial. The Rankin Focused Assessment is brief and practical for use in multicenter clinical trials and quality improvement activities.

Executive summary of the National Institute of Neurological Disorders and Stroke conference on Emergency Neurologic Clinical Trials Network.

On March 17 and 18, 2004, the National Institute of Neurological Disorders and Stroke sponsored a conference to explore the advisability of establishing a multicenter network designed to perform clinical trials in emergency neurologic conditions. The Emergency Neurology Clinical Trials Network concept was discussed by 25 clinicians and scientists from multiple disciplines. The goal was to improve the overall functional outcome for patients with acute neurologic emergencies. The participants discussed various aspects necessary in evaluating the potential of such a network, including the organization structure, funding, cost-effectiveness, and clinical conditions to be studied. A neurologic emergencies network that is not disease specific would open opportunities for clinical research that would facilitate rapid effective treatment of emergency conditions and lead to improved patient outcomes. In addition, the cost savings realized through economies of scale of such a network would allow more research to be performed at a lower cost.