Olfactory Impairment and the Risk of Major Adverse Cardiovascular Outcomes in Older Adults.

BACKGROUND: Olfactory impairment is common in older adults and may be associated with adverse cardiovascular health; however, empirical evidence is sparse. We examined olfaction in relation to the risk of coronary heart disease (CHD), stroke, and congestive heart failure (CHF). METHODS AND RESULTS: This study included 2537 older adults (aged 75.6±2.8 years) from the Health ABC (Health, Aging, and Body Composition) study with olfaction assessed by the 12-item Brief Smell Identification Test in 1999 to 2000, defined as poor (score ≤8), moderate (9-10), or good (11-12). The outcomes were incident CHD, stroke, and CHF. During up to a 12-year follow-up, 353 incident CHD, 258 stroke, and 477 CHF events were identified. Olfaction was statistically significantly associated with incident CHF, but not with CHD or stroke. After adjusting for demographics, risk factors, and biomarkers of CHF, the cause-specific hazard ratio (HR) of CHF was 1.32 (95% CI, 1.05-1.66) for moderate and 1.28 (95% CI, 1.01-1.64) for poor olfaction. These associations were robust in preplanned subgroup analyses by age, sex, race, and prevalent CHD/stroke. While the subgroup results were not statistically significantly different, the association of olfaction with CHF appeared to be evident among participants who reported very good to excellent health (HR, 1.47 [95% CI, 1.01-2.14] for moderate; and 1.76 [95% CI, 1.20-2.58] for poor olfaction), but not among those with fair to poor self-reported health (HR, 1.04 [95% CI, 0.64-1.70] for moderate; and 0.92 [95% CI, 0.58-1.47] for poor olfaction). CONCLUSIONS: In community-dwelling older adults, a single olfaction test was associated with a long-term risk for incident CHF, particularly among those reporting very good to excellent health.

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.

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.

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.

Factors Associated With Premature Termination of Hyperacute Stroke Trials: A Review.

BACKGROUND: We performed a review of acute stroke trials to determine features associated with premature termination of trial enrollment, defined by the authors as not meeting preplanned sample size. METHODS AND RESULTS: MEDLINE was searched for randomized clinical stroke trials published in 9 major clinical journals between 2013 and 2022. We included randomized clinical trials that were phase 2 or 3 with a preplanned sample size ≥100 and a time-to-treatment within 24 hours of onset for transient ischemic attack, ischemic stroke, or intracerebral hemorrhage. Data were abstracted on trial features including trial design, inclusion criteria, imaging, location and number of sites, masking, treatment complexity, control group (standard therapy, placebo), industry involvement, and preplanned stopping rules (futility and efficacy). Least absolute shrinkage and selection operator regression was used to select the most important factors associated with premature termination; then, a multivariable logistic regression was fit including only the least absolute shrinkage and selection operator selected variables. Of 1475 studies assessed, 98 trials met eligibility criteria. Forty-five (46%) trials were prematurely terminated, of which 27% were stopped for benefit/efficacy, 20% for lack of money/slow enrollment, 18% for futility, 16% for newly available evidence, 17% for other reasons, and 4% due to harm. Complex trials (adjusted odds ratio [aOR], 2.76 [95% CI, 1.13-7.49]), presence of a futility rule (aOR, 4.43 [95% CI, 1.62-17.91]), and exclusion of prestroke dependency (none/slight disability only; aOR, 2.19 [95% CI, 0.84-6.72] versus dependency allowed) were identified as the strongest predictors. CONCLUSIONS: Nearly half of acute stroke trials were terminated prematurely. Broadening inclusion criteria and simplifying trial design may decrease the likelihood of unplanned termination, whereas planned futility analyses may appropriately terminate trials early, saving money and resources.

Covert Cerebrovascular Changes in People With Heart Disease: A Systematic Review and Meta-Analysis.

BACKGROUND AND OBJECTIVES: To determine the prevalence of silent brain infarction (SBI) and cerebral small vessel disease (CSVD) in adults with atrial fibrillation (AF), coronary artery disease, heart failure or cardiomyopathy, heart valve disease, and patent foramen ovale (PFO), with comparisons between those with and without recent stroke and an exploration of associations between heart disease and SBI/CSVD. METHODS: Medline, Embase, and Cochrane Library were systematically searched for hospital-based or community-based studies reporting SBI/CSVD in people with heart disease. Data were extracted from eligible studies. Outcomes were SBI (primary) and individual CSVD subtypes. Summary prevalence (95% confidence intervals [CIs]) were obtained using random-effects meta-analysis. Pooled prevalence ratios (PRs) (95% CI) were calculated to compare those with heart disease with available control participants without heart disease from studies. RESULTS: A total of 221 observational studies were included. In those with AF, the prevalence was 36% (31%-41%) for SBI (70 studies, N = 13,589), 25% (19%-31%) for lacune (26 studies, N = 7,172), 62% (49%-74%) for white matter hyperintensity/hypoattenuation (WMH) (34 studies, N = 7,229), and 27% (24%-30%) for microbleed (44 studies, N = 13,654). Stratification by studies where participants with recent stroke were recruited identified no differences in the prevalence of SBI across subgroups (phomogeneity = 0.495). Results were comparable across participants with different heart diseases except for those with PFO, in whom there was a lower prevalence of SBI [21% (13%-30%), 11 studies, N = 1,053] and CSVD. Meta-regressions after pooling those with any heart disease identified associations of increased (study level) age and hypertensives with more SBIs and WMH (pregression <0.05). There was no evidence of a difference in the prevalence of microbleed between those with and without heart disease (PR [95% CI] 1.1 [0.7-1.7]), but a difference was seen in the prevalence of SBI and WMH (PR [95% CI] 2.3 [1.6-3.1] and 1.7 [1.1-2.6], respectively). DISCUSSION: People with heart disease have a high prevalence of SBI (and CSVD), which is similar in those with vs without recent stroke. More research is required to assess causal links and implications for management. TRIAL REGISTRATION INFORMATION: PROSPERO CRD42022378272 (crd.york.ac.uk/PROSPERO/).

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.

Study protocol for a pilot clinical trial to understand neural mechanisms of response to a psychological treatment for pain and anxiety in pediatric functional abdominal pain disorders (FAPD).

BACKGROUND: Functional abdominal pain disorders (FAPD) are the most common chronic pain conditions of childhood and are made worse by co-occurring anxiety. Our research team found that the Aim to Decrease Pain and Anxiety Treatment (ADAPT), a six-session coping skills program using cognitive behavioral therapy strategies, was effective in improving pain-related symptoms and anxiety symptoms compared to standard care. In follow-up, this current randomized clinical trial (RCT) aims to test potential neural mechanisms underlying the effect of ADAPT. Specifically, this two-arm RCT will explore changes in amygdalar functional connectivity (primary outcome) following the ADAPT protocol during the water loading symptom provocation task (WL-SPT). Secondary (e.g., changes in regional cerebral blood flow via pulsed arterial spin labeling MRI) and exploratory (e.g., the association between the changes in functional connectivity and clinical symptoms) outcomes will also be investigated. METHODS: We will include patients ages 11 to 16 years presenting to outpatient pediatric gastroenterology care at a midwestern children's hospital with a diagnosis of FAPD plus evidence of clinical anxiety based on a validated screening tool (the Generalized Anxiety Disorder-7 [GAD-7] measure). Eligible participants will undergo baseline neuroimaging involving the WL-SPT, and assessment of self-reported pain, anxiety, and additional symptoms, prior to being randomized to a six-week remotely delivered ADAPT program plus standard medical care or standard medical care alone (waitlist). Thereafter, subjects will complete a post assessment neuroimaging visit similar in nature to their first visit. CONCLUSIONS: This small scale RCT aims to increase understanding of potential neural mechanisms of response to ADAPT. TRIAL REGISTRATION: ClinicalTrials.gov registration: NCT03518216.

COVID-19 Infection Is Associated With Poor Outcomes in Patients With Intracerebral Hemorrhage.

BACKGROUND: Patients with ischemic stroke and concomitant COVID-19 infection have worse outcomes than those without this infection, but the impact of COVID-19 on hemorrhagic stroke remains unclear. We aimed to assess if COVID-19 worsens outcomes in intracerebral hemorrhage (ICH). METHODS AND RESULTS: We conducted an observational study of ICH outcomes using Get With The Guidelines Stroke data. We compared patients with ICH who were COVID-19 positive and negative during the pandemic (March 2020-February 2021) and prepandemic (March 2019-February 2020). Main outcomes were poor functional outcome (defined as a modified Rankin scale score of 4 to 6 at discharge), mortality, and discharge to a skilled nursing facility or hospice. The first stage included 60 091 patients with ICH who were COVID-19 negative and 1326 COVID-19 positive. In multivariable analyses, patients with ICH with versus without COVID-19 infection had 68% higher odds of poor outcome (odds ratio [OR], 1.68 [95% CI, 1.41-2.01]), 51% higher odds of mortality (OR, 1.51 [95% CI, 1.33-1.71]), and 66% higher odds of being discharged to a skilled nursing facility/hospice (OR, 1.66 [95% CI, 1.43-1.93]). The second stage included 62 743 prepandemic and 64 681 intrapandemic cases with ICH. In multivariable analyses, patients with ICH admitted during versus before the COVID-19 pandemic had 10% higher odds of poor outcomes (OR, 1.10 [95% CI, 1.07-1.14]), 5% higher mortality (OR, 1.05 [95% CI, 1.02-1.08]), and no significant difference in the risk of being discharged to a skilled nursing facility/hospice (OR, 0.93 [95% CI, 0.90-0.95]). CONCLUSIONS: The pathophysiology of the COVID-19 infection and changes in health care delivery during the pandemic played a role in worsening outcomes in the patient population with ICH.

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.

Olfactory impairment and the risk of major adverse cardiovascular outcomes in older adults.

Background: Olfactory impairment is common in older adults and may be associated with adverse cardiovascular health; however, empirical evidence is sparse. Objective: To examine olfaction and the risk of coronary heart disease (CHD), stroke, and congestive heart failure (CHF). Methods: This study included 2,537 older adults (aged 75.6±2.8 years) from the Health ABC Study with olfaction assessed by the 12-item Brief Smell Identification Test in 1999-2000, defined as poor (score ≤8), moderate (9-10), or good (11-12). The outcomes were incident CHD, stroke, and CHF. Results: During up to 12-year follow-up, 353 incident CHD, 258 stroke, and 477 CHF events were identified. Olfaction was associated with incident CHF, but not with CHD or stroke. After adjusting for demographics, the cause-specific hazard ratio (HR) of CHF was 1.35 (95% confidence interval (CI): 1.08, 1.70) for moderate and 1.39 (95%CI: 1.09, 1.76) for poor olfaction. With additional adjustment for lifestyle, chronic diseases, and biomarkers of CHF, the HR was modestly attenuated to 1.32 (95%CI: 1.05, 1.66) for moderate and 1.28 (95%CI: 1.01, 1.64) for poor olfaction. These associations were robust in pre-planned subgroup analyses by age, sex, race, and prevalent CHD/stroke. However, the associations appeared to be evident among participants who reported very-good-to-excellent health (HR=1.47 (95%CI: 1.02, 2.13) for moderate and 1.76, (95%CI: 1.20, 2.57) for poor olfaction). In contrast, null association with CHF was found among those with fair-to-poor self-reported health. Conclusions: In community-dwelling older adults, a single olfaction test was associated with a long-term risk for incident CHF, particularly among those reporting very-good-to-excellent health.

Insurance-Based Disparities in Stroke Center Access in California: A Network Science Approach.

BACKGROUND: Our objectives were to determine whether there is an association between ischemic stroke patient insurance and likelihood of transfer overall and to a stroke center and whether hospital cluster modified the association between insurance and likelihood of stroke center transfer. METHODS: This retrospective network analysis of California data included every nonfederal hospital ischemic stroke admission from 2010 to 2017. Transfers from an emergency department to another hospital were categorized based on whether the patient was discharged from a stroke center (primary or comprehensive). We used logistic regression models to examine the relationship between insurance (private, Medicare, Medicaid, uninsured) and odds of (1) any transfer among patients initially presenting to nonstroke center hospital emergency departments and (2) transfer to a stroke center among transferred patients. We used a network clustering method to identify clusters of hospitals closely connected through transfers. Within each cluster, we quantified the difference between insurance groups with the highest and lowest proportion of transfers discharged from a stroke center. RESULTS: Of 332 995 total ischemic stroke encounters, 51% were female, 70% were ≥65 years, and 3.5% were transferred from the initial emergency department. Of 52 316 presenting to a nonstroke center, 3466 (7.1%) were transferred. Relative to privately insured patients, there were lower odds of transfer and of transfer to a stroke center among all groups (Medicare odds ratio, 0.24 [95% CI, 0.22-0.26] and 0.59 [95% CI, 0.50-0.71], Medicaid odds ratio, 0.26 [95% CI, 0.23-0.29] and odds ratio, 0.49 [95% CI, 0.38-0.62], uninsured odds ratio, 0.75 [95% CI, 0.63-0.89], and 0.72 [95% CI, 0.6-0.8], respectively). Among the 14 identified hospital clusters, insurance-based disparities in transfer varied and the lowest performing cluster (also the largest; n=2364 transfers) fully explained the insurance-based disparity in odds of stroke center transfer. CONCLUSIONS: Uninsured patients had less stroke center access through transfer than patients with insurance. This difference was largely explained by patterns in 1 particular hospital cluster.

Recent Vitamin K Antagonist Use and Intracranial Hemorrhage After Endovascular Thrombectomy for Acute Ischemic Stroke.

Importance: Use of oral vitamin K antagonists (VKAs) may place patients undergoing endovascular thrombectomy (EVT) for acute ischemic stroke caused by large vessel occlusion at increased risk of complications. Objective: To determine the association between recent use of a VKA and outcomes among patients selected to undergo EVT in clinical practice. Design, Setting, and Participants: Retrospective, observational cohort study based on the American Heart Association's Get With the Guidelines-Stroke Program between October 2015 and March 2020. From 594 participating hospitals in the US, 32 715 patients with acute ischemic stroke selected to undergo EVT within 6 hours of time last known to be well were included. Exposure: VKA use within the 7 days prior to hospital arrival. Main Outcome and Measures: The primary end point was symptomatic intracranial hemorrhage (sICH). Secondary end points included life-threatening systemic hemorrhage, another serious complication, any complications of reperfusion therapy, in-hospital mortality, and in-hospital mortality or discharge to hospice. Results: Of 32 715 patients (median age, 72 years; 50.7% female), 3087 (9.4%) had used a VKA (median international normalized ratio [INR], 1.5 [IQR, 1.2-1.9]) and 29 628 had not used a VKA prior to hospital presentation. Overall, prior VKA use was not significantly associated with an increased risk of sICH (211/3087 patients [6.8%] taking a VKA compared with 1904/29 628 patients [6.4%] not taking a VKA; adjusted odds ratio [OR], 1.12 [95% CI, 0.94-1.35]; adjusted risk difference, 0.69% [95% CI, -0.39% to 1.77%]). Among 830 patients taking a VKA with an INR greater than 1.7, sICH risk was significantly higher than in those not taking a VKA (8.3% vs 6.4%; adjusted OR, 1.88 [95% CI, 1.33-2.65]; adjusted risk difference, 4.03% [95% CI, 1.53%-6.53%]), while those with an INR of 1.7 or lower (n = 1585) had no significant difference in the risk of sICH (6.7% vs 6.4%; adjusted OR, 1.24 [95% CI, 0.87-1.76]; adjusted risk difference, 1.13% [95% CI, -0.79% to 3.04%]). Of 5 prespecified secondary end points, none showed a significant difference across VKA-exposed vs VKA-unexposed groups. Conclusions and Relevance: Among patients with acute ischemic stroke selected to receive EVT, VKA use within the preceding 7 days was not associated with a significantly increased risk of sICH overall. However, recent VKA use with a presenting INR greater than 1.7 was associated with a significantly increased risk of sICH compared with no use of anticoagulants.

A multi-site pilot randomized clinical trial of the Treatment and Education Approach for Childhood-onset Lupus (TEACH) program: study design and COVID-19 adaptations.

BACKGROUND: Childhood-onset Systemic Lupus Erythematosus (cSLE) is an autoimmune disease associated with fatigue, mood symptoms, and pain. Fortunately, these symptoms are potentially modifiable with psychological intervention such as cognitive-behavioral therapy (CBT). The Treatment and Education Approach for Childhood-onset Lupus (TEACH) program is a CBT intervention developed to target these symptoms for adolescents and young adults with cSLE. This pilot randomized controlled trial (RCT) aims to determine the feasibility and effect of TEACH for youth with cSLE. Adjustments to the study protocol following the COVID-19 pandemic are also described. METHODS: This two-arm multisite RCT will explore the feasibility (primary outcome) and effect (secondary outcome) of a remotely delivered TEACH protocol. Participants will be randomized to a six-week remotely delivered TEACH program plus medical treatment as usual (TAU) or TAU alone. We will include patients ages 12-22 years presenting to rheumatology clinics from six sites. Validated measures of fatigue, depressive symptoms, and pain will be obtained at baseline and approximately eight and 20 weeks later. Protocol adjustments were also made due to the COVID-19 pandemic, in collaboration with the investigative team, which included patients and caregivers. CONCLUSIONS: Findings from this multi-site RCT aim to document the feasibility of TEACH and provide an estimate of effect of a remotely delivered TEACH protocol on fatigue, depression, and pain symptoms in youth with cSLE as compared to standard medical treatment alone. This findings may positively impact clinical care for patients with cSLE. CLINICAL TRIALS: gov registration: NCT04335643.

Responder analysis confirms results of a stroke transitional care trial but provides more interpretable results.

OBJECTIVES: Interpreting between-group differences in patient-reported outcome measures can be challenging. Responder analyses, which compare the proportions of patients who achieve a meaningful clinical change, represent a more interpretable approach. We conducted a secondary responder analysis of the Michigan Stroke Transitions Trial (MISTT). STUDY DESIGN AND SETTING: The MISTT randomized 265 patients with stroke to three treatment groups: usual care [UC], social work case management [SWCM], or social work case management plus access to a patient-oriented website [SWCM + website]. Two Patient-Reported Outcomes Measurement and Information System (PROMIS) Global-10 subscales (representing physical and mental health) and 5 additional patient-reported outcomes were collected at baseline and 90-days. Responder analyses were conducted using modified Poisson and linear regression using published minimal important differences. Multiple imputation was used to address missing data. RESULTS: For the PROMIS-10 global physical health subscale, responders were 80% more common in the SWCM + website group compared to the UC group (relative risk = 1.8, 95% confidence interval [CI]: 1.0, 3.1), with a number needed to treat of 7 (95% CI: 3, 112). No significant treatment effects were observed for the PROMIS-10 global mental health subscale. CONCLUSION: Results of this responder analysis were largely consistent with the original trial analysis but have the advantage of presenting treatment effects using more clinically interpretable number needed to treat metrics.

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.