Sex Differences in Trends in Stroke Recurrence and Postrecurrence Mortality 2000-2020: Population-Based Brain Attack Surveillance in Corpus Christi Project.

OBJECTIVE: This study was undertaken to delineate 21-year sex-specific trends in recurrence and postrecurrence mortality. METHODS: Between 2000 and 2020, first-ever ischemic stroke (IS) patients, ascertained from the population-based BASIC (Brain Attack Surveillance in Corpus Christi) project in South Texas, were followed for recurrent stroke and all-cause mortality until December 31, 2020. Multivariable regression models with an interaction between calendar year and sex were used to estimate sex-specific trends and sex differences in recurrence and postrecurrence mortality. RESULTS: Of the 6,057 IS patients (median age = 69 years, 49.8% women), 654 (10.8%) had a recurrence and 399 (47.7%) had postrecurrence mortality during 5 years of follow-up. In 2000, women had 2.5% higher albeit non-statistically significant 5-year risk of recurrence than men in absolute scale. With the trend declining in women by 7.6% (95% confidence interval [CI] = -10.8 to -4.5%) and in men by 3.6% (95% CI = -6.5% to -0.7%), the risk at the end of the study period was 1.5% (95% CI = -0.3% to 3.6%) lower among women than men. For postrecurrence mortality, the risk was 10.2% lower among women in 2000, but the sex difference was 3.3% by the end of the period, which was due to a larger overall increase in the risk among women than men over the entire time period. INTERPRETATION: The declines in recurrent stroke suggest successful secondary stroke prevention, especially in women. However, the continued high postrecurrence mortality among both sexes at the end of study period emphasizes the need for ongoing interventions to improve prognosis in those who have had recurrent cerebrovascular events. ANN NEUROL 2024;96:332-342.

Utilization and Reporting of Patient-Reported Outcome Measures in Randomized Clinical Trials of Acute Stroke (2010-2020).

BACKGROUND: Patient-reported outcome measures (PROMs) describe health status from the perspective of the patient. There is growing interest in incorporating PROMs into clinical trials, but the extent that such measures are used in contemporary stroke trials is uncertain. We sought to determine how often acute stroke trials included PROMs as outcome measures and assessed the completeness of methodological reporting. METHODS: We searched MEDLINE for randomized controlled trials published in 9 high-impact journals between 2010 and 2020. Eligible studies were phase 2 or 3 trials that tested therapeutic interventions within 1 month of stroke onset. Using the trial's primary publication and protocol, we abstracted key study characteristics including all primary and secondary outcome measures. We defined PROMs as self-reported measures of quality of life, symptoms, or function collected without interpretation of an external party. RESULTS: Of 116 trials that met eligibility, 57 (49%) included at least 1 PROM. Of these, 41 trials (35%) included a PROM in its primary publication, while 16 (14%) identified a PROM in its protocol. Only 1 trial used a PROM as a primary outcome. Among the 57 total trials, the most commonly used measures were Euro-QOL (n=41, 72%), Stroke Impact Scale (n=10, 18%), and Short-Form 36 (n=6, 11%). Trials were more likely to include a PROM if they were published after 2016, were phase 3, or included only hemorrhagic stroke. Of the 41 trials that included a PROM in the primary publication, 40 (97%) provided PROM results, but only 9 (22%) found statistically significant differences between treatment groups. Quality of methodological reporting was generally poor. CONCLUSIONS: Half of contemporary acute stroke trials published in high-impact journals listed at least 1 PROM as a secondary outcome, but they played a minor role in the presentation of the final trial results. Inclusion of PROMs in acute stroke trials requires greater attention during both the design and reporting phases of the trial. REGISTRATION: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42019128727.

Emergency Medical Services Compliance With Prehospital Stroke Quality Metrics Is Associated With Faster Stroke Evaluation and Treatment.

BACKGROUND: Emergency medical services (EMS) is an important link in the stroke chain of recovery. Various prehospital quality metrics have been proposed for prehospital stroke care, but their individual impact is uncertain. We sought to measure associations between EMS quality metrics and downstream stroke care. METHODS: This is a retrospective analysis of a cohort of EMS-transported stroke patients assembled through a linkage between Michigan's EMS and stroke registries. We used multivariable regression to quantify the independent associations between EMS quality metric compliance (dispatch within 90 seconds of 911 call, prehospital stroke screen documentation [Prehospital stroke scale], glucose check, last known well time, maintenance of scene times ≤15 minutes, hospital prenotification, and intravenous line placement) and shorter door-to-CT times (door-to-CT ≤25), accounting for EMS recognition, age, sex, race, stroke subtype, severity, and duration of symptoms. We then developed a simple EMS quality score based on metrics associated with early CT and examined its associations with hospital stroke evaluation times, treatment, and patient outcomes. RESULTS: Five thousand seven hundred seven EMS-transported stroke cases were linked to prehospital records from January 2018 through June 2019. In multivariable analysis, prehospital stroke scale documentation (adjusted odds ratio, 1.4 [1.2-1.6]), glucose check (1.3 [1.1-1.6]), on-scene time ≤15 minutes (1.6 [1.4-1.9]), hospital prenotification ([2.0 [1.4-2.9]), and intravenous line placement (1.8 [1.5-2.1]) were independently associated with a door-to-CT ≤25 minutes. A 5-point quality score (1 point for each element) was therefore developed. In multivariable analysis, a 1-point higher EMS quality score was associated with a shorter time from EMS contact to CT (-9.2 [-10.6 to -7.8] minutes; P<0.001) and thrombolysis (-4.3 [-6.4 to -2.2] minutes; P<0.001), and higher odds of discharge to home (adjusted odds ratio, 1.1 [1.0-1.2]; P=0.002). CONCLUSIONS: Five EMS actions recommended by national guidelines were associated with rapid CT imaging. A simple quality score derived from these measures was also associated with faster stroke evaluation, greater odds of reperfusion treatment, and discharge to home.

Twenty Years of Get With The Guidelines-Stroke: Celebrating Past Successes, Lessons Learned, and Future Challenges.

The Get With The Guidelines-Stroke program which, began 20 years ago, is one of the largest and most important nationally representative disease registries in the United States. Its importance to the stroke community can be gauged by its sustained growth and widespread dissemination of findings that demonstrate sustained increases in both the quality of care and patient outcomes over time. The objectives of this narrative review are to provide a brief history of Get With The Guidelines-Stroke, summarize its major successes and impact, and highlight lessons learned. Looking to the next 20 years, we discuss potential challenges and opportunities for the program.

Mapping the Ecological Terrain of Stroke Prehospital Delay: A Nationwide Registry Study.

BACKGROUND: Delays in hospital presentation limit access to acute stroke treatments. While prior research has focused on patient-level factors, broader ecological and social determinants have not been well studied. We aimed to create a geospatial map of prehospital delay and examine the role of community-level social vulnerability. METHODS: We studied patients with ischemic stroke who arrived by emergency medical services in 2015 to 2017 from the American Heart Association Get With The Guidelines-Stroke registry. The primary outcome was time to hospital arrival after stroke (in minutes), beginning at last known well in most cases. Using Geographic Information System mapping, we displayed the geography of delay. We then used Cox proportional hazard models to study the relationship between community-level factors and arrival time (adjusted hazard ratios [aHR] <1.0 indicate delay). The primary exposure was the social vulnerability index (SVI), a metric of social vulnerability for every ZIP Code Tabulation Area ranging from 0.0 to 1.0. RESULTS: Of 750 336 patients, 149 145 met inclusion criteria. The mean age was 73 years, and 51% were female. The median time to hospital arrival was 140 minutes (Q1: 60 minutes, Q3: 458 minutes). The geospatial map revealed that many zones of delay overlapped with socially vulnerable areas (https://harvard-cga.maps.arcgis.com/apps/webappviewer/index.html?id=08f6e885c71b457f83cefc71013bcaa7). Cox models (aHR, 95% CI) confirmed that higher SVI, including quartiles 3 (aHR, 0.96 [95% CI, 0.93-0.98]) and 4 (aHR, 0.93 [95% CI, 0.91-0.95]), was associated with delay. Patients from SVI quartile 4 neighborhoods arrived 15.6 minutes [15-16.2] slower than patients from SVI quartile 1. Specific SVI themes associated with delay were a community's socioeconomic status (aHR, 0.80 [95% CI, 0.74-0.85]) and housing type and transportation (aHR, 0.89 [95% CI, 0.84-0.94]). CONCLUSIONS: This map of acute stroke presentation times shows areas with a high incidence of delay. Increased social vulnerability characterizes these areas. Such places should be systematically targeted to improve population-level stroke presentation times.

Care Transition Interventions to Improve Stroke Outcomes: Evidence Gaps in Underserved and Minority Populations.

In many countries hospital length of stay after an acute stroke admission is typically just a few days, therefore, most of a person's recovery from stroke occurs in the community. Care transitions, which occur when there is a change in, or handoff between 2 different care settings or providers, represent an especially vulnerable period for patients and caregivers. For some patients with stroke the return home is associated with substantial practical, psychosocial, and health-related challenges leading to substantial burden for the individual and caregiver. Underserved and minority populations, because of their exposure to poor environmental, social, and economic conditions, as well as structural racism and discrimination, are especially vulnerable to the problems of complicated care transitions which in turn, can negatively impact stroke recovery. Overall, there remain significant unanswered questions about how to promote optimal recovery in the post-acute care period, particularly for those from underserved communities. Evidence is limited on how best to support patients after they have returned home where they are required to navigate the chronic stages of stroke with little direct support from health professionals.

Prognosis of Individual-Level Mobility and Daily Activities Recovery From Acute Care to Community, Part 2: A Proof-of-Concept Single Group Prospective Cohort Study.

OBJECTIVE: To demonstrate a proof-of-concept for prognostic models of post-stroke recovery on activity level outcomes. DESIGN: Longitudinal cohort with repeated measures from acute care, inpatient rehabilitation, and post-discharge follow-up to 6 months post-stroke. SETTING: Enrollment from a single Midwest USA inpatient rehabilitation facility with community follow-up. PARTICIPANTS: One-hundred fifteen persons recovering from stroke admitted to an acute rehabilitation facility (N=115). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE(S): Activity Measure for Post-Acute Care Basic Mobility and Daily Activities domains administered as 6 Clicks and patient-reported short forms. RESULTS: The final Basic Mobility model defined a group-averaged trajectory rising from a baseline (pseudo-intercept) T score of 35.5 (P<.001) to a plateau (asymptote) T score of 56.4 points (P<.001) at a negative exponential rate of -1.49 (P<.001). Individual baseline scores varied by age, acute care tissue plasminogen activator, and acute care length of stay. Individual plateau scores varied by walking speed, acute care tissue plasminogen activator, and lower extremity Motricity Index scores. The final Daily Activities model defined a group-averaged trajectory rising from a baseline T score of 24.5 (P<.001) to a plateau T score of 41.3 points (P<.001) at a negative exponential rate of -1.75 (P<.001). Individual baseline scores varied by acute care length of stay, and plateau scores varied by self-care, upper extremity Motricity Index, and Berg Balance Scale scores. CONCLUSIONS: As a proof-of-concept, individual activity-level recovery can be predicted as patient-level trajectories generated from electronic medical record data, but models require attention to completeness and accuracy of data elements collected on a fully representative patient sample.

Prognosis of Individual-Level Mobility and Self-Care Stroke Recovery During Inpatient Rehabilitation, Part 1: A Proof-of-Concept Single Group Retrospective Cohort Study.

OBJECTIVE: To demonstrate feasibility of generating predictive short-term individual trajectory recovery models after acute stroke by extracting clinical data from an electronic medical record (EMR) system. DESIGN: Single-group retrospective patient cohort design. SETTING: Stroke rehabilitation unit at an independent inpatient rehabilitation facility (IRF). PARTICIPANTS: Cohort of 1408 inpatients with acute ischemic or hemorrhagic stroke with a mean ± SD age of 66 (14.5) years admitted between April 2014 and October 2019 (N=1408). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: 0-100 Rasch-scaled Functional Independence Measure (FIM) Mobility and Self-Care subscales. RESULTS: Unconditional models were best-fit on FIM Mobility and Self-Care subscales by spline fixed-effect functions with knots at weeks 1 and 2, and random effects on the baseline (FIM 0-100 Rasch score at IRF admission), initial rate (slope at time zero), and second knot (change in slope pre-to-post week 2) parameters. The final Mobility multivariable model had intercept associations with Private/Other Insurance, Ischemic Stroke, Serum Albumin, Motricity Index Lower Extremity, and FIM Cognition; and initial slope associations with Ischemic Stroke, Private/Other and Medicaid Insurance, and FIM Cognition. The final Self-Care multivariable model had intercept associations with Private/Other Insurance, Ischemic Stroke, Living with One or More persons, Serum Albumin, and FIM Cognition; and initial slope associations with Ischemic Stroke, Private/Other and Medicaid Insurance, and FIM Cognition. Final models explained 52% and 27% of the variance compared with unconditional Mobility and Self-Care models. However, some EMR data elements had apparent coding errors or missing data, and desired elements from acute care were not available. Also, unbalanced outcome data may have biased trajectories. CONCLUSIONS: We demonstrate the feasibility of developing individual-level prognostic models from EMR data; however, some data elements were poorly defined, subject to error, or missing for some or all cases. Development of prognostic models from EMR will require improvements in EMR data collection and standardization.

Measuring Stroke Quality: Methodological Considerations in Selecting, Defining, and Analyzing Quality Measures.

Knowledge about stroke and its management is growing rapidly and stroke systems of care must adapt to deliver evidence-based care. Quality improvement initiatives are essential for translating knowledge from clinical trials and recommendations in guidelines into routine clinical practice. This review focuses on issues central to the measurement of the quality of stroke care, including selection and definition of quality measures, identification of the eligible patient cohorts, optimization of data quality, and considerations for data analysis and interpretation.

Achieving More Rapid Door-to-Needle Times and Improved Outcomes in Acute Ischemic Stroke in a Nationwide Quality Improvement Intervention.

BACKGROUND: The benefits of tPA (tissue-type plasminogen activator) in acute ischemic stroke are time-dependent. However, delivery of thrombolytic therapy rapidly after hospital arrival was initially occurring infrequently in hospitals in the United States, discrepant with national guidelines. METHODS: We evaluated door-to-needle (DTN) times and clinical outcomes among patients with acute ischemic stroke receiving tPA before and after initiation of 2 successive nationwide quality improvement initiatives: Target: Stroke Phase I (2010-2013) and Target: Stroke Phase II (2014-2018) from 913 Get With The Guidelines-Stroke hospitals in the United States between April 2003 and September 2018. RESULTS: Among 154 221 patients receiving tPA within 3 hours of stroke symptom onset (median age 72 years, 50.1% female), median DTN times decreased from 78 minutes (interquartile range, 60-98) preintervention, to 66 minutes (51-87) during Phase I, and 50 minutes (37-66) during Phase II (P<0.001). Proportions of patients with DTN ≤60 minutes increased from 26.4% to 42.7% to 68.6% (P<0.001). Proportions of patients with DTN ≤45 minutes increased from 10.1% to 17.7% to 41.4% (P<0.001). By the end of the second intervention, 75.4% and 51.7% patients achieved 60-minute and 45-minute DTN goals. Compared with the preintervention period, hospitals during the second intervention period (2014-2018) achieved higher rates of tPA use (11.7% versus 5.6%; adjusted odds ratio, 2.43 [95% CI, 2.31-2.56]), lower in-hospital mortality (6.0% versus 10.0%; adjusted odds ratio, 0.69 [0.64-0.73]), fewer bleeding complication (3.4% versus 5.5%; adjusted odds ratio, 0.68 [0.62-0.74]), and higher rates of discharge to home (49.6% versus 35.7%; adjusted odds ratio, 1.43 [1.38-1.50]). Similar findings were found in sensitivity analyses of 185 501 patients receiving tPA within 4.5 hours of symptom onset. CONCLUSIONS: A nationwide quality improvement program for acute ischemic stroke was associated with substantial improvement in the timeliness of thrombolytic therapy start, increased thrombolytic treatment, and improved clinical outcomes.

Emulating 3 Clinical Trials That Compare Stroke Rehabilitation at Inpatient Rehabilitation Facilities With Skilled Nursing Facilities.

OBJECTIVE: To inform the design of a potential future randomized controlled trial (RCT), we emulated 3 trials where patient-level outcomes were compared after stroke rehabilitation at inpatient rehabilitation facilities (IRFs) with skilled nursing facilities (SNFs). DESIGN: Trials were emulated using a 1:1 matched propensity score analysis. The 3 trials differed because facilities from rehabilitation networks with different case volumes were compared. Rehabilitation network case volumes were based on the number of patients with stroke that each hospital discharged to each specific IRF or SNF. Trial 1 included 60,529 patients from all networks, trial 2 included 34,444 patients from networks with medium and large case volumes (ie, ≥5 patients), and trial 3 included 19,161 patients from networks with large case volumes (ie, ≥10 patients). The E values were calculated to estimate the minimum strength that an unmeasured confounder would need to be to nullify the results. SETTING: A national sample of IRFs and SNFs from across the United States. PARTICIPANTS: Fee-for-service Medicare patients with acute stroke who received IRF or SNF based rehabilitation. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: One-year successful community discharge (home for >30 consecutive days) and all-cause mortality. RESULTS: Overall, 29,500, 15,156, and 7450 patients were matched for trials 1, 2, and 3. For 1-year successful community discharge, absolute risk differences for IRF patients were 0.21 (95% CI, 0.20-0.22), 0.17 (95% CI, 0.16-0.19), and 0.12 (95% CI, 0.10-0.14) in trials 1, 2, and 3, respectively. For 1-year all-cause mortality, corresponding risk differences were -0.11 (95% CI, -0.12 to -0.11), -0.11 (95% CI, -0.12 to -0.09), and -0.08 (95% CI, -0.10 to -0.06). The E values indicated that a moderately sized unmeasured confounder, with a relative risk of 1.6-2.0 would nullify differences in successful community discharge. CONCLUSIONS: IRF patients had superior outcomes, but differences were attenuated when IRFs and SNFs from larger rehabilitation networks were compared. The vulnerability of the findings to unmeasured confounding supports the need for an RCT.

Rationale for a Clinical Trial That Compares Acute Stroke Rehabilitation at Inpatient Rehabilitation Facilities to Skilled Nursing Facilities: Challenges and Opportunities.

In the United States, approximately 400,000 patients with acute stroke are discharged annually to inpatient rehabilitation facilities (IRFs) or skilled nursing facilities (SNFs). Typically, IRFs provide time-intensive therapy for an average of 2-3 weeks, whereas SNFs provide more moderately intensive therapy for 4-5 weeks. The factors that influence discharge to an IRF or SNF are multifactorial and poorly understood. The complexity of these factors in combination with subjective clinical indications contributes to large variations in the use of IRFs and SNFs. This has significant financial implications for health care expenditure, given that stroke rehabilitation at IRFs costs approximately double that at SNFs. To control health care spending without compromising outcomes, the Institute of Medicine has stated that policy reforms that promote more efficient use of IRFs and SNFs are critically needed. A major barrier to the formulation of such policies is the highly variable and low-quality evidence for the comparative effectiveness of IRF- vs SNF-based stroke rehabilitation. The current evidence is limited by the inability of observational data to control for residual confounding, which contributes to substantial uncertainty around any magnitude of benefit for IRF- vs SNF-based care. Furthermore, it is unclear which specific patients would receive the most benefit from each setting. A randomized controlled trial addresses these issues, because random treatment allocation facilitates an equitable distribution of measured and unmeasured confounders. We discuss several measurement, practical, and ethical issues of a trial and provide our rationale for design suggestions that overcome some of these issues.

Association of Recent Use of Non-Vitamin K Antagonist Oral Anticoagulants With Intracranial Hemorrhage Among Patients With Acute Ischemic Stroke Treated With Alteplase.

Importance: Current guidelines recommend against use of intravenous alteplase in patients with acute ischemic stroke who are taking non-vitamin K antagonist oral anticoagulants (NOACs). Objective: To evaluate the safety and functional outcomes of intravenous alteplase among patients who were taking NOACs prior to stroke and compare outcomes with patients who were not taking long-term anticoagulants. Design, Setting, and Participants: A retrospective cohort study of 163 038 patients with acute ischemic stroke either taking NOACs or not taking anticoagulants prior to stroke and treated with intravenous alteplase within 4.5 hours of symptom onset at 1752 US hospitals participating in the Get With The Guidelines-Stroke program between April 2015 and March 2020, with complementary data from the Addressing Real-world Anticoagulant Management Issues in Stroke registry. Exposures: Prestroke treatment with NOACs within 7 days prior to alteplase treatment. Main Outcomes and Measures: The primary outcome was symptomatic intracranial hemorrhage occurring within 36 hours after intravenous alteplase administration. There were 4 secondary safety outcomes, including inpatient mortality, and 7 secondary functional outcomes assessed at hospital discharge, including the proportion of patients discharged home. Results: Of 163 038 patients treated with intravenous alteplase (median age, 70 [IQR, 59 to 81] years; 49.1% women), 2207 (1.4%) were taking NOACs and 160 831 (98.6%) were not taking anticoagulants prior to their stroke. Patients taking NOACs were older (median age, 75 [IQR, 64 to 82] years vs 70 [IQR, 58 to 81] years for those not taking anticoagulants), had a higher prevalence of cardiovascular comorbidities, and experienced more severe strokes (median National Institutes of Health Stroke Scale score, 10 [IQR, 5 to 17] vs 7 [IQR, 4 to 14]) (all standardized differences >10). The unadjusted rate of symptomatic intracranial hemorrhage was 3.7% (95% CI, 2.9% to 4.5%) for patients taking NOACs vs 3.2% (95% CI, 3.1% to 3.3%) for patients not taking anticoagulants. After adjusting for baseline clinical factors, the risk of symptomatic intracranial hemorrhage was not significantly different between groups (adjusted odds ratio [OR], 0.88 [95% CI, 0.70 to 1.10]; adjusted risk difference [RD], -0.51% [95% CI, -1.36% to 0.34%]). There were no significant differences in the secondary safety outcomes, including inpatient mortality (6.3% for patients taking NOACs vs 4.9% for patients not taking anticoagulants; adjusted OR, 0.84 [95% CI, 0.69 to 1.01]; adjusted RD, -1.20% [95% CI, -2.39% to -0%]). Of the secondary functional outcomes, 4 of 7 showed significant differences in favor of the NOAC group after adjustment, including the proportion of patients discharged home (45.9% vs 53.6% for patients not taking anticoagulants; adjusted OR, 1.17 [95% CI, 1.06 to 1.29]; adjusted RD, 3.84% [95% CI, 1.46% to 6.22%]). Conclusions and Relevance: Among patients with acute ischemic stroke treated with intravenous alteplase, use of NOACs within the preceding 7 days, compared with no use of anticoagulants, was not associated with a significantly increased risk of intracranial hemorrhage.

Case-Fatality and Functional Outcome after Subarachnoid Hemorrhage (SAH) in INternational STRoke oUtComes sTudy (INSTRUCT).

BACKGROUND: There are few large population-based studies of outcomes after subarachnoid hemorrhage (SAH) than other stroke types. METHODS: We pooled data from 13 population-based stroke incidence studies (10 studies from the INternational STRroke oUtComes sTudy (INSTRUCT) and 3 new studies; N=657). Primary outcomes were case-fatality and functional outcome (modified Rankin scale score 3-5 [poor] vs. 0-2 [good]). Harmonized patient-level factors included age, sex, health behaviours (e.g. current smoking at baseline), comorbidities (e.g.history of hypertension), baseline stroke severity (e.g. NIHSS >7) and year of stroke. We estimated predictors of case-fatality and functional outcome using Poisson regression and generalized estimating equations using log-binomial models respectively at multiple timepoints. RESULTS: Case-fatality rate was 33% at 1 month, 43% at 1 year, and 47% at 5 years. Poor functional outcome was present in 27% of survivors at 1 month and 15% at 1 year. In multivariable analysis, predictors of death at 1-month were age (per decade increase MRR 1.14 [1.07-1.22]) and SAH severity (MRR 1.87 [1.50-2.33]); at 1 year were age (MRR 1.53 [1.34-1.56]), current smoking (MRR 1.82 [1.20-2.72]) and SAH severity (MRR 3.00 [2.06-4.33]) and; at 5 years were age (MRR 1.63 [1.45-1.84]), current smoking (MRR 2.29 [1.54-3.46]) and severity of SAH (MRR 2.10 [1.44-3.05]). Predictors of poor functional outcome at 1 month were age (per decade increase RR 1.32 [1.11-1.56]) and SAH severity (RR 1.85 [1.06-3.23]), and SAH severity (RR 7.09 [3.17-15.85]) at 1 year. CONCLUSION: Although age is a non-modifiable risk factor for poor outcomes after SAH, however, severity of SAH and smoking are potential targets to improve the outcomes.

Reporting of Results by Sex in Randomized Controlled Trials of Acute Stroke Therapies (2010-2020).

Background and Purpose: When reporting primary results from randomized controlled trials, recommendations include reporting results by sex. We reviewed the reporting of results by sex in contemporary acute stroke randomized controlled trials. Methods: We searched MEDLINE for articles reporting the primary results of phase 2 or 3 stroke randomized controlled trials published between 2010 and June 2020 in one of nine major clinical journals. Eligible trials were restricted to those with a therapeutic intervention initiated within one month of stroke onset. Of primary interest was the reporting of results by sex for the primary outcome. We performed bivariate analyses using Fisher exact tests to identify study-level factors associated with reporting by sex and investigated temporal trends using an exact test for trend. Results: Of the 115 studies identified, primary results were reported by sex in 37% (n=42). Reporting varied significantly by journal, with the New England Journal of Medicine (61%) and Lancet journals (40%) having the highest rates (P=0.03). Reporting also differed significantly by geographic region (21% Europe versus 48% Americas, P=0.03), trial phase (13% phase 2 versus 40% phase 3, P=0.05), and sample size (24% <250 participants versus 61% >750 participants, P<0.01). Although not statistically significant (P=0.11), there was a temporal trend in favor of greater reporting among later publications (25% 2010­2012 versus 48% 2019­2020). Conclusions: Although reporting of primary trial results by sex improved from 2010 to 2020, the prevalence of reporting in major journals is still low. Further efforts are required to encourage journals and authors to comply with current reporting recommendations.

Benefits and Risks of Dual Versus Single Antiplatelet Therapy for Secondary Stroke Prevention: A Systematic Review for the 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack.

BACKGROUND: Dual antiplatelet therapy (DAPT) after ischemic stroke or transient ischemic attack may reduce recurrent stroke but also increase severe bleeding compared with single antiplatelet therapy (SAPT). The American Heart Association/American Stroke Association convened an evidence review committee to perform a systematic review and meta-analysis of the benefits and risks of DAPT compared with SAPT for secondary ischemic stroke prevention. METHODS: The Medline, Embase, and Cochrane databases were searched on December 5, 2019, to identify phase III or IV randomized controlled trials (n≥100) from December 1999 to December 2019. We calculated unadjusted relative risks (RRs) and performed meta-analyses of studies based on the duration of treatment (short [≤90 days] versus long [>90 days]). RESULTS: Three short-duration randomized controlled trials were identified that enrolled mostly patients with minor stroke or high risk transient ischemic attack. In these trials, DAPT, compared with SAPT, was associated with a lower 90-day risk of recurrent ischemic stroke (pooled RR, 0.68 [95% CI, 0.55-0.83], I 2=37.1%). There was no significant increase in major bleeding with DAPT in short-duration trials (pooled RR, 1.88 [95% CI, 0.93-3.83], I 2=8.9%). In 2 long-duration treatment randomized controlled trials (mean treatment duration, 18-40 months), DAPT was not associated with a significant reduction in recurrent ischemic stroke (pooled RR, 0.89 [95% CI, 0.79-1.02], I 2=1.4%), but was associated with a higher risk of major bleeding (pooled RR, 2.42 [95% CI, 1.37-4.30], I 2=75.5%). CONCLUSIONS: DAPT was more effective than SAPT for prevention of secondary ischemic stroke when initiated early after the onset of minor stroke/high-risk transient ischemic attack and treatment duration was <90 days. However, when the treatment duration was longer and initiated later after stroke or transient ischemic attack onset, DAPT was not more effective than SAPT for ischemic stroke prevention and it increased the risk of bleeding.

Deintensification or No Statin Treatment Is Associated With Higher Mortality in Patients With Ischemic Stroke or Transient Ischemic Attack.

Background and Purpose: Practice guidelines recommend that most patients receive moderate- or high-potency statins after ischemic stroke or transient ischemic attack (TIA) of atherosclerotic origin. We tested the association of different patterns of potency for prescribed statin therapy­assessed before admission and at hospital discharge for ischemic stroke or TIA­on mortality in a large, nationwide sample of US Veterans. Methods: The study population included patients with an ischemic stroke or TIA occurring during 2011 at any of the 134 Veterans Health Administration facilities. We used electronic outpatient pharmacy files to identify statin dose at hospital admission and within 7 days after hospital discharge. We categorized statin dosing as low, moderate, or high potency; moderate or high potency was considered at goal. We created 6 mutually exclusive groups to reflect patterns of statin potency from hospital admission to discharge: goal to goal, low to goal, goal to low or goal to none (deintensification), none to none, none to low, and low to low. We used logistic regression to compare 30-day and 1-year mortality across statin potency groups. Results: The population included 9380 predominately White (71.1%) men (96.3%) who were hospitalized for stroke or TIA. In this sample, 34.1% of patients (n=3194) were discharged off a statin medication. Deintensification occurred in 14.0% of patients (n=1312) and none to none in 20.5% (n=1924). Deintensification and none to none were associated with a higher odds of mortality as compared with goal to goal (adjusted odds ratio 1-year mortality: deintensification versus goal to goal, 1.26 [95% CI, 1.02­1.57]; none to none versus goal to goal, 1.59 [95% CI, 1.30­1.93]). Adjustments for differences in baseline characteristics using propensity weighted scores demonstrated similar results. Conclusions: Underutilization of statins, including no treatment or underdosing after stroke (deintensification), was observed in approximately one-third of veterans with ischemic stroke or TIA and was associated with higher mortality when compared with patients who were at goal for statin prescription dosing.

Opening Pandora's Box: From Readmissions to Transitional Care Patient-Centered Outcome Measures.

BACKGROUND: Measuring the effectiveness of transitional care interventions has historically relied on health care utilization as the primary outcome. Although the Care Transitions Measure was the first outcome measure specifically developed for transitional care, its applicability beyond the hospital-to-home transition is limited. There is a need for patient-centered outcome measures (PCOMs) to be developed for transitional care settings (ie, TC-PCOMs) to ensure that outcomes are both meaningful to patients and relevant to the particular care transition. The overall objective of this paper is to describe the opportunities and challenges of integrating TC-PCOMs into research and practice. METHODS AND RESULTS: This narrative review was conducted by members of the Patient-Centered Outcomes Research Institute (PCORI) Transitional Care Evidence to Action Network. We define TC-PCOMs as outcomes that matter to patients because they account for their individual experiences, concerns, preferences, needs, and values during the transition period. The cardinal features of TC-PCOMs should be that they are developed following direct input from patients and stakeholders and reflect their lived experience during the transition in question. Although few TC-PCOMs are currently available, existing patient-reported outcome measures could be adapted to become TC-PCOMs if they incorporated input from patients and stakeholders and are validated for the relevant care transition. CONCLUSION: Establishing validated TC-PCOMs is crucial for measuring the responsiveness of transitional care interventions and optimizing care that is meaningful to patients.

Accuracy and Implications of Hemorrhagic Stroke Recognition by Emergency Medical Services.

Background Hemorrhagic stroke is a medical emergency that requires rapid identification and treatment. Despite playing a critical role in the emergency response to hemorrhagic stroke patients, a minimal amount is known about the quality of emergency medical services (EMS) care for this condition. The objectives of this study were to quantify EMS hemorrhagic stroke recognition, identify predictors of accurate EMS recognition, and examine associations between EMS recognition, quality of prehospital care, and patient outcomes. Methods: Consecutive EMS-transported hemorrhagic strokes were identified from medical records at 4 primary stroke centers. Data regarding prehospital care were abstracted from EMS records and linked to in-hospital data. Clinical predictors of accurate EMS recognition were examined using logistic regression. EMS performance measure compliance and hospital outcomes were also compared among EMS recognized and unrecognized hemorrhagic strokes. Results: Over 24 months, EMS-transported 188 hemorrhagic stroke patients; 108 (57.4%) were recognized by EMS. Recognized cases had higher rates of stroke scale documentation (84.3% vs. 20.0%, p < 0.001); multivariable logistic regression confirmed a strong independent relationship between stroke scale documentation and recognition (adjusted OR 15.1 [5.6 to 40.7]). Recognized cases also had shorter on-scene times (15.5 vs. 21 min, p < 0.001) and door-to-computed tomography (DTCT) acquisition times (20 vs. 47 min, p < 0.001). Conclusions: Among EMS-transported hemorrhagic stroke cases, stroke screen documentation was strongly associated with EMS stroke recognition, which was in turn associated with higher quality of EMS care and faster computed tomography (CT) scans upon emergency department arrival.

Effect of transitional care stroke case management interventions on caregiver outcomes: the MISTT randomized trial.

This study reports on outcomes for 169 caregivers enrolled in the Michigan Stroke Transitions Trial (MISTT), an RCT of social work case management for stroke patients returning home. A mixed-model approach examined the mean change from 7- to 90-days post-discharge with group-by-time interactions for differences between treatment groups. Caregivers reported few life changes or depressive symptoms from caregiving. There was no significant change over time or treatment effects. Negative aspects of stroke caregiving may take longer to develop. Focused caregiver assessment at discharge and a better understanding of how caregiving develops over time may improve the type and timing of support.