Race-Ethnic Disparities in Rates of Declination of Thrombolysis for Stroke.

BACKGROUND AND OBJECTIVES: Prior regional or single-center studies have noted that 4% to 7% of eligible patients with acute ischemic stroke (AIS) decline IV tissue plasminogen activator (tPA). We sought to determine the prevalence of tPA declination in a nationwide registry of patients with AIS and to investigate differences in declination by race/ethnicity. METHODS: We used the Get With The Guidelines-Stroke registry to identify patients with AIS eligible for tPA and admitted to participating hospitals between January 1, 2016, and March 28, 2019. We compared patient demographics and admitting hospital characteristics between tPA-eligible patients who received and those who declined tPA. Using multivariable logistic regression, we determined patient and hospital factors associated with tPA declination. RESULTS: Among 177,115 tPA-eligible patients with AIS at 1,976 sites, 6,545 patients (3.7%) had tPA declination as the sole documented reason for not receiving tPA. Patients declining treatment were slightly older, were more likely to be female, arrived more often at off-hours and earlier after symptom onset, and were more likely to present to Primary Stroke Centers. Compared with non-Hispanic White, non-Hispanic Black race/ethnicity was independently associated with increased (adjusted odds ratio [aOR] 1.21, 95% CI 1.11-1.31), Asian race/ethnicity with decreased (aOR 0.72, 95% CI 0.58-0.88), and Hispanic ethnicity (any race) with similar odds of tPA declination (OR 0.98, 95% CI 0.86-1.13) in multivariable analysis. DISCUSSION: Although the overall prevalence of tPA declination is low, eligible non-Hispanic Black patients are more likely and Asian patients less likely to decline tPA than non-Hispanic White patients. Reducing rates of tPA declinations among non-Hispanic Black patients may be an opportunity to address disparities in stroke care.

Achievement and quality measure attainment in patients hospitalized with atrial fibrillation: Results from The Get With The Guidelines - Atrial Fibrillation (GWTG-AFIB) registry.

BACKGROUND: The Get With The Guidelines - Atrial Fibrillation (GWTG-AFIB) Registry uses achievement and quality measures to improve the care of patients with atrial fibrillation (AF). We sought to evaluate overall and site-level variation in attainment of these measures among sites participating in the GWTG-AFIB Registry. METHODS: From the GWTG-AFIB registry, we included patients with AF admitted between 1/3/2013 and 6/30/2019. We described patient-level attainment and variation in attainment across sites of 6 achievement measures with 1) defect-free scores (percent of patients with all eligible measures attained), and 2) composite opportunity scores (percent of all eligible patient measures attained). We also described attainment of 11 quality measures at the patient-level. RESULTS: Among 80,951 patients hospitalized for AF (age 70±13 years, 47.0% female; CHA2DS2-VASc 3.6±1.8) at 132 sites. Site-level defect-free scores ranged from 4.7% to 85.8% (25th, 50th, 75th percentile: 32.7%, 52.1%, 64.4%). Composite opportunity scores ranged from 39.4% to 97.5% (25th, 50th, 75th: 68.1%, 80.3%, 87.1%). Attainment was notably low for the following quality measures: 1) aldosterone antagonist prescription when ejection fraction ≤35% (29% of those eligible); and 2) avoidance of antiplatelet therapy with OAC in patients without coronary/peripheral artery disease (81% of those eligible). CONCLUSIONS: Despite high overall attainment of care measures across GWTG-AFIB registry sites, large site variation was present with meaningful opportunities to improve AF care beyond OAC prescription, including but not limited to prescription of aldosterone antagonists in those with AF and systolic dysfunction and avoidance of non-indicated adjunctive antiplatelet therapy.

Outcomes of Endovascular Therapy in Patients With Prestroke Mobility Impairment.

Background and Purpose: Patients with prestroke mobility impairment (PSMI) were excluded from endovascular clinical trials. There are limited data regarding safety and outcomes of endovascular thrombectomy in this population. We used a large, national data set (Get With The Guidelines­Stroke) to evaluate the safety and outcomes of endovascular thrombectomy in patients with PSMI. Methods: We included patients who underwent endovascular thrombectomy in the Get With The Guidelines­Stroke registry between 2015 and 2019. PSMI was defined as the inability to ambulate independently. Generalized estimating equations for logistic regression models were used to evaluate the association between PSMI and outcomes. Results: Of 56 762 patients treated with endovascular thrombectomy, 2919 (5.14%) had PSMI. PSMI was not associated with symptomatic intracranial hemorrhage (6.0% versus 5.4%; P=0.979). In-hospital death or discharge to hospice occurred in 32.3% of patients with PSMI versus 17.5% without PSMI (adjusted odds ratio, 1.45 [1.32­1.58]). Conclusions: While procedural adverse outcomes were no higher in patients with PSMI, further study is necessary to determine clinical benefit in this population.

Patterns of antidepressant therapy and clinical outcomes among ischaemic stroke survivors.

BACKGROUND AND PURPOSE: Depression is common after stroke and is often treated with antidepressant medications (AD). ADs have also been hypothesised to improve stroke recovery, although recent randomised trials were neutral. We investigated the patterns of in-hospital AD initiation after ischaemic stroke and association with clinical and readmission outcomes. METHODS: All Medicare fee-for-service beneficiaries aged 65 or older hospitalised for ischaemic stroke in participating Get With The Guidelines-Stroke hospitals between April and December 2014 were eligible for this analysis. Outcome measures included days alive and not in a healthcare institution (home time), all-cause mortality and readmission within 1-year postdischarge. Propensity score (PS)-adjusted logistic regression models were used to evaluate the associations between AD use and each outcome measure. We also compared outcomes in patients prescribed selective serotonin reuptake inhibitors (SSRIs) AD versus those prescribed non-SSRI ADs. RESULTS: Of 21 805 AD naïve patients included in this analysis, 1835 (8.4%) were started on an AD at discharge. Patients started on an AD had higher rates of depression and prior ischaemic stroke, presented with higher admission National Institutes of Health Stroke Scale score and were less likely to be discharged home. Similarly, patients started on an SSRI had lower rates of discharge to home. Adjusting for stroke severity, patients started on an AD had worse all-cause mortality, all-cause readmission, major adverse cardiac events, readmission for depression and decreased home-time. However, AD use was also associated with an increased risk for the sepsis, a falsification endpoint, suggesting the presence of residual confounding. CONCLUSIONS: Patients with ischaemic stroke initiated on AD therapy are at increased risk of poor clinical outcomes and readmission even after PS adjustment, suggesting that poststroke depression requiring medication is a poor prognostic sign. Further research is needed to explore the reasons why depression is associated with worse outcome, and whether AD treatment modifies this risk or not.

Cryptogenic stroke: Contemporary trends, treatments, and outcomes in the United States.

BACKGROUND: Nationwide data on patients with cryptogenic stroke (CS) are lacking. We evaluated patient and hospital characteristics, in-hospital treatments, and discharge outcomes among patients with CS compared with other subtypes in the Get With The Guidelines (GWTG)-Stroke registry. METHODS: We identified patients with ischemic stroke (IS) admitted to GWTG-Stroke participating hospitals between January 1, 2016, and September 30, 2017, with documented National Institutes of Health Stroke Scale (NIHSS) scale and stroke etiology (cardioembolic [CE], large artery atherosclerosis [LAA], small vessel occlusion [SVO], other determined etiology [OTH], or CS). Using multivariable logistic regression, we compared hospital treatments and discharge outcomes by subtype, adjusted for patient and hospital characteristics. RESULTS: Among 316,623 patients from 1,687 hospitals, there were 63,301 (20.0%) patients with CS. In multivariable analysis, patients with CS received IV thrombolysis more often than other subtypes and had lower mortality than CE, LAA, and OTH but higher mortality than SVO. They were more likely to be discharged home than all other subtypes and be independent at discharge than LAA, OTH, or SVO. CONCLUSIONS: In a large contemporary nationwide registry, CS accounted for 20% of ISs among patients with a documented stroke etiology. Patients with CS had a distinct profile of treatments and outcomes relative to other subtypes. Improved subtype documentation and further research into CS are warranted to improve care and outcomes for patients with stroke.

Disease Burden Following Non-Cardioembolic Minor Ischemic Stroke or High-Risk TIA: A GWTG-Stroke Study.

BACKGROUND: Limited real-world data are available on outcomes following non-cardioembolic minor ischemic stroke (IS) or high-risk transient ischemic attack (TIA), particularly in the United States (US). We examined outcomes and Medicare payments following any severity IS or TIA as well as the subgroup with minor IS or high-risk TIA. METHODS: Medicare beneficiaries >65 years were identified using US nationwide Get with the Guidelines (GWTG)-Stroke Registry linked to Medicare claims data. The cohort consisted of patients enrolled in Medicare fee-for-service plan, hospitalized with non-cardioembolic IS or TIA between 2011 and 2014, segmenting a subgroup with minor IS (National Institute of Health Stroke Scale [NIHSS] ≤5) or high-risk TIA (ABCD2-score ≥6) compatible with the THALES clinical trial population. Outcomes included functional status at discharge, clinical outcomes (all-cause mortality, ischemic stroke, and hemorrhagic stroke, individually and as a composite), hospitalizations, and population average inpatient Medicare payments following non-cardioembolic IS or TIA. RESULTS: The THALES-compatible cohort included 62,518 patients from 1471 hospitals. At discharge, 37.0% were unable to ambulate without assistance, and 96.2% were prescribed antiplatelet therapy. Cumulative incidences at 30 days, 90 days, and 1 year for the composite outcome were 3.7%, 7.6%, and 17.2% and 2.4%, 4.0%, and 7.3% for subsequent stroke. The mean Medicare payment for the index hospitalization was $7951. The cumulative all-cause inpatient Medicare spending per patient (with or without any subsequent admission) at 30 days and 1 year from discharge was $1451 and $8105, respectively. CONCLUSIONS: The burden of illness for minor IS/high-risk TIA patients indicates an important unmet need. Improved therapeutic options may offer a significant impact on both patient outcomes and Medicare spending.

Quality of Care and Outcomes Among Medicare Advantage vs Fee-for-Service Medicare Patients Hospitalized With Heart Failure.

Importance: Medicare Advantage (MA), a private insurance plan option, now covers one-third of all Medicare beneficiaries. Although patients with cardiovascular disease enrolled in MA have been reported to receive higher quality of care in the ambulatory setting than patients enrolled in fee-for-service (FFS) Medicare, it is unclear whether MA is associated with higher quality in patients hospitalized with heart failure, or alternatively, if incentives to reduce utilization under MA plans may be associated with worse care. Objective: To determine whether there are differences in quality of care received and in-hospital outcomes among patients enrolled in MA vs FFS Medicare. Design, Setting, and Participants: Observational, retrospective cohort study of patients hospitalized with heart failure in hospitals participating in the Get With the Guidelines-Heart Failure registry. Exposures: Medicare Advantage enrollment. Main Outcomes and Measures: In-hospital mortality, discharge disposition, length of stay, and 4 heart failure achievement measures. Results: Of 262 626 patients hospitalized with heart failure, 93 549 (35.6%) were enrolled in MA and 169 077 (64.4%) in FFS Medicare. The median (interquartile range) age was 78 (70-85) years for patients enrolled in MA and 78 (69-86) years for patients enrolled in FFS Medicare. Standard mean differences in age, sex, prevalence of comorbidities, or objective measures on admission, including vital signs and laboratory values, were less than 10%. After adjustment, there were no statistically significant differences in receipt of evidence-based ß-blockers when indicated; angiotensin-converting enzyme inhibitor, angiotensin II receptor blockers, or angiotensin receptor-neprilysin inhibitors at discharge; measurement of left ventricular function; and postdischarge appointments by Medicare insurance type. Patients enrolled in MA, however, had higher odds of being discharged directly home (adjusted odds ratio [AOR], 1.16; 95% CI, 1.13-1.19; P < .001) relative to patients enrolled in FFS Medicare and lower odds of being discharged within 4 days (AOR, 0.97; 95% CI, 0.93-1.00; P = .04). There was no significant difference in in-hospital mortality between patients with MA and patients with FFS Medicare (AOR, 0.98; 95% CI, 0.92-1.03; P = .42). Conclusions and Relevance: Among patients hospitalized with heart failure, no observable benefit was noted in quality of care or in-hospital mortality between those enrolled in MA vs FFS Medicare, except lower use of post-acute care facilities. As MA continues to grow, it will be important to ensure that participating private plans provide an added value to the patients they cover to justify the higher administrative costs compared with traditional FFS Medicare.

Home Health Care Use and Post-Discharge Outcomes After Heart Failure Hospitalizations.

OBJECTIVES: This study compared the characteristics of Medicare beneficiaries who were hospitalized for heart failure (HF) and then discharged home who received home health care (HHC) to the characteristics of those who did not, and examined associations among HHC and readmission and mortality rates. BACKGROUND: After hospitalization for HF, some patients receive HHC. However, the use of HHC over time, the factors associated with its use, and the post-discharge outcomes after receiving it are not well studied. METHODS: This study used Get With The Guidelines-HF data, merged with Medicare fee-for-service claims. Propensity score matching and Cox proportional hazards models were used to evaluate the associations between HHC and post-discharge outcomes. RESULTS: From 2005 to 2015, 95,531 patients were admitted for HF, and 32,697 (34.2%) received HHC after discharge. The rate of HHC increased over time from 31.4% to 36.1% (p < 0.001). HHC recipients were older, more likely to be female, and had more comorbidities. HHC was associated with a higher risk of all-cause 30-day readmission (hazard ratio [HR]: 1.25; 95% confidence interval [CI]: 1.20 to 1.30), HF-specific 30-day readmission (HR: 1.20; 95% CI: 1.13 to 1.28), all-cause 90-day readmission (HR: 1.23; 95% CI: 1.19 to 1.26), HF-specific 90-day readmission (HR: 1.16; 95% CI: 1.11 to 1.22), and all-cause 30-and 90-day mortality, respectively (HR: 1.70; 95% CI: 1.56 to 1.86) and HR: 1.49; 95% CI: 1.41 to 1.57) compared to those who did not receive HHC. CONCLUSIONS: Use of HHC after HF hospitalization increased among Medicare beneficiaries. HHC recipients were older and sicker than non-HHC recipients. Although HHC was associated with a higher risk of readmissions and mortality, this finding should be interpreted cautiously, given the presence of unmeasured variables that could affect receipt of HHC. Research is needed to determine whether the results reflect appropriate health care use.

Antiplatelet patterns and outcomes in patients with atrial fibrillation not prescribed an anticoagulant after stroke.

BACKGROUND: To determine association of discharge antiplatelet therapy prescription with 1-year outcomes among patients with AF admitted with acute ischemic stroke and discharged without oral anticoagulation. METHODS: In a retrospective cohort study from the Get With The Guidelines-Stroke registry, we identified all Medicare fee-for-service beneficiaries 65 years or older with AF or atrial flutter admitted with acute ischemic stroke and discharged without oral anticoagulation from April 2003 through December 2014, and we determined association of discharge antiplatelet therapy prescription with 1-year outcomes using Medicare claims data. Primary outcomes were 1-year mortality and composite endpoint of major adverse cardiovascular/neurologic/bleeding events (MACNBE). RESULTS: Of 64,228 subjects (median [interquartile range] age, 84 [78-89] years; 62.5% female), 54,621 (85.0%) were discharged with antiplatelet therapy, and 9607 (15.0%) were discharged with no antithrombotic therapy. The unadjusted rates of 1-year mortality were lower among patients receiving antiplatelet therapy (37.3%) than among those receiving no antithrombotic therapy (48.1%); unadjusted rates of MACNBE were lower for those receiving antiplatelet therapy (45.5%) compared with those receiving no antithrombotic therapy (55.2%). After adjusting for potential confounders, antiplatelet therapy prescription was associated with reduced 1-year mortality (adjusted hazard ratio [HR] 0.64, 95% confidence interval [CI] 0.62-0.66, P < .001) and MACNBE (adjusted HR 0.69, 95% CI 0.67-0.71, P < .001). CONCLUSIONS: Among Medicare beneficiaries with AF admitted for acute ischemic stroke but not discharged on oral anticoagulant therapy, antiplatelet therapy, compared with no antithrombotic therapy, was associated with reduced 1-year mortality and MACNBE.

Comparison of Characteristics and Outcomes of Patients With Heart Failure With Preserved Ejection Fraction With Versus Without Hyperuricemia or Gout.

Hyperuricemia and gout are common in patients with heart failure (HF) and are associated with poor outcomes. Data describing hyperuricemia and gout in patients with HF with preserved ejection fraction (HFpEF) are limited. We used data from the Duke University Health System to describe characteristics of patients with HFpEF and hyperuricemia (serum uric acid >6 mg/dl) or gout (gout diagnosis or gout medication within the previous year) and to explore associations with 5-year outcomes (death and hospitalization). We identified 7,004 patients in the Duke University Health System with a known diagnosis of HFpEF who underwent transthoracic echocardiography between January 1, 2005 and December 31, 2017. A total of 1,136 (16.2%) patients with HFpEF also had hyperuricemia or gout. Patients with HFpEF and hyperuricemia or gout had a greater co-morbidity burden, more echocardiographic findings of cardiac remodeling, and higher unadjusted rates of all-cause death, all-cause hospitalization, and HF hospitalization compared with those with HFpEF without hyperuricemia or gout. After multivariable adjustment, patients with HFpEF and hyperuricemia or gout had a significantly higher rates of first all-cause hospitalization (adjusted hazard ratio 1.10 [95% confidence interval 1.02 to 1.19]; p = 0.020) and recurrent all-cause hospitalization (associated rate ratio 1.13 [95% confidence interval 1.01 to 1.25]; p = 0.026). After adjustment, no significant differences in death or HF hospitalization were observed. In conclusion, patients with HFpEF and hyperuricemia or gout were found to have a higher burden of co-morbidities and a higher rate of all-cause hospitalization, even after multivariable adjustment, compared to patients with HFpEF without hyperuricemia or gout.

Elevated Uric Acid Prevalence and Clinical Outcomes in Patients with Heart Failure with Preserved Ejection Fraction: Insights from RELAX.

PURPOSE: We aimed to 1) describe characteristics of patients with heart failure with preserved ejection fraction (HFpEF) enrolled in RELAX stratified by normal or elevated baseline serum uric acid (sUA) level; 2) evaluate the association between sUA level and surrogate clinical measures; and 3) assess associations between changes in sUA level over time and changes in surrogate clinical measures. METHODS: We analyzed 212 patients with HFpEF and normal or elevated (>6 mg/dL) baseline sUA measurements from the RELAX trial. Variables examined included clinical characteristics, cardiopulmonary exercise testing, 6-minute walk testing, quality of life, echocardiography, and serum biomarker testing. Baseline characteristics between groups were compared and scatter plots with quadratic regression lines and linear regression modeling were used to assess the relationship between baseline sUA and clinical measures. Kaplan-Meier curves were used to describe composite death or cardiovascular/renal hospitalization. RESULTS: The prevalence of elevated baseline sUA was 68.9%. Patients with elevated sUA had more baseline comorbidities and poorer functional status on cardiopulmonary exercise testing than those without. After adjustment, significant associations between baseline sUA levels and cystatin C, N-terminal pro B-type natriuretic peptide, high-sensitivity troponin I, and high-sensitivity C-reactive protein were identified. Higher baseline sUA was also associated with worsening peak VO2, 6-minute walk testing, and left ventricular mass. No significant association was found between baseline sUA levels and the composite of death or cardiovascular/renal hospitalization at 24 weeks. CONCLUSION: sUA is an important marker of comorbidities and functional status in patients with HFpEF. Clinical trials of sUA-lowering therapies in patients with HFpEF are promising.

Comparative effectiveness of hysterectomy versus myomectomy on one-year health-related quality of life in women with uterine fibroids.

OBJECTIVE: To compare long-term health-related quality of life (HRQOL) 1 year after hysterectomy or myomectomy for treatment of uterine fibroids (UFs) and to determine whether route of procedure, race, or age affected improvements in HRQOL. DESIGN: Prospective cohort study. SETTING: Eight clinical sites throughout the United States. PATIENT(S): A total of 1,113 premenopausal women with UFs who underwent hysterectomy or myomectomy as part of Comparing Options for Management: Patient-Centered Results for Uterine Fibroids. INTERVENTION(S): None. MAIN OUTCOME MEASURE (S): Self-reported HRQOL measures including Uterine Fibroid Symptom Quality of Life, the European QOL 5 Dimension Health Questionnaire, and the visual analog scale at baseline and 1-year after hysterectomy or myomectomy. RESULT (S): Hysterectomy patients were older with a longer history of symptomatic UF compared with myomectomy patients. There were no differences in baseline HRQOL. After adjustment for baseline differences between groups, compared with myomectomy, patients' HRQOL (95% confidence interval [CI], 5.4, 17.2) and symptom severity (95% CI, -16.3, -8.8) were significantly improved with hysterectomy. When stratified across race/ethnicity and age, hysterectomy had higher HRQOL scores compared with myomectomy. There was little difference in HRQOL (95% CI, 0.1 [-9.5, 9.6]) or symptom severity (95% CI, -3.4 [-10, 3.2]) between abdominal hysterectomy and abdominal myomectomy. CONCLUSION (S): HRQOL improved in all women 1 year after hysterectomy or myomectomy. Hysterectomy patients reported higher HRQOL summary scores compared with myomectomy patients. When stratified by route, minimally invasive hysterectomy had better HRQOL scores than minimally invasive myomectomy. There was little difference in scores with abdominal approaches.

Clinical Effectiveness of Direct Oral Anticoagulants vs Warfarin in Older Patients With Atrial Fibrillation and Ischemic Stroke: Findings From the Patient-Centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) Study.

IMPORTANCE: Current guidelines recommend direct oral anticoagulants (DOACs) over warfarin for stroke prevention in patients with atrial fibrillation (AF) who are at high risk. Despite demonstrated efficacy in clinical trials, real-world data of DOACs vs warfarin for secondary prevention in patients with ischemic stroke are largely based on administrative claims or have not focused on patient-centered outcomes. OBJECTIVE: To examine the clinical effectiveness of DOACs (dabigatran, rivaroxaban, or apixaban) vs warfarin after ischemic stroke in patients with AF. DESIGN, SETTING, AND PARTICIPANTS: This cohort study included patients who were 65 years or older, had AF, were anticoagulation naive, and were discharged from 1041 Get With The Guidelines-Stroke-associated hospitals for acute ischemic stroke between October 2011 and December 2014. Data were linked to Medicare claims for long-term outcomes (up to December 2015). Analyses were completed in July 2018. EXPOSURES: DOACs vs warfarin prescription at discharge. MAIN OUTCOMES AND MEASURES: The primary outcomes were home time, a patient-centered measure defined as the total number of days free from death and institutional care after discharge, and major adverse cardiovascular events. A propensity score-overlap weighting method was used to account for differences in observed characteristics between groups. RESULTS: Of 11 662 survivors of acute ischemic stroke (median [interquartile range] age, 80 [74-86] years), 4041 (34.7%) were discharged with DOACs and 7621 with warfarin. Except for National Institutes of Health Stroke Scale scores (median [interquartile range], 4 [1-9] vs 5 [2-11]), baseline characteristics were similar between groups. Patients discharged with DOACs (vs warfarin) had more days at home (mean [SD], 287.2 [114.7] vs 263.0 [127.3] days; adjusted difference, 15.6 [99% CI, 9.0-22.1] days) during the first year postdischarge and were less likely to experience major adverse cardiovascular events (adjusted hazard ratio [aHR], 0.89 [99% CI, 0.83-0.96]). Also, in patients receiving DOACs, there were fewer deaths (aHR, 0.88 [95% CI, 0.82-0.95]; P < .001), all-cause readmissions (aHR, 0.93 [95% CI, 0.88-0.97]; P = .003), cardiovascular readmissions (aHR, 0.92 [95% CI, 0.86-0.99]; P = .02), hemorrhagic strokes (aHR, 0.69 [95% CI, 0.50-0.95]; P = .02), and hospitalizations with bleeding (aHR, 0.89 [95% CI, 0.81-0.97]; P = .009) but a higher risk of gastrointestinal bleeding (aHR, 1.14 [95% CI, 1.01-1.30]; P = .03). CONCLUSIONS AND RELEVANCE: In patients with acute ischemic stroke and AF, DOAC use at discharge was associated with better long-term outcomes relative to warfarin.

Short-Term Health-Related Quality of Life After Hysterectomy Compared With Myomectomy for Symptomatic Leiomyomas.

OBJECTIVE: To compare short-term health-related quality of life (HRQOL) 6-12 weeks after hysterectomy or myomectomy for the treatment of symptomatic leiomyomas. METHODS: We conducted a prospective comparative effectiveness analysis of data. In an existing multisite registry, we compared 6-12-week postsurgical HRQOL using the disease-specific Uterine Fibroid Symptom Quality of Life and the generic EuroQoL 5-Dimension Health Questionnaire, in women from the ages of 18-54 years with documented leiomyomas undergoing hysterectomy or myomectomy. Propensity score weighting was used to adjust for confounding, and analyses were also stratified by route of surgery. RESULTS: A total of 1,295 patients (727 with hysterectomy and 568 with myomectomy) enrolled from registry initiation in November 2015 until June 2018 met inclusion criteria. At baseline, leiomyoma-specific HRQOL (44.0±25.4 and 50.2±25.3, P<.01), symptom severity (60.7±23.6 and 51.7±24.6, P<.01), and generic HRQOL (69.3±20.4 and. 73.4±18.9, P<.01) were significantly different between the hysterectomy compared with myomectomy groups, respectively. Differences were eliminated by propensity adjustment. Substantial improvement in HRQOL measures were seen in both groups at 6-12 weeks, with the mean propensity-adjusted symptom severity score 4 points lower in hysterectomy patients (mean difference -4.6; 95% CI -7.0 to -2.3), compared with myomectomy patients. Hysterectomy patients had better scores on the concern and self-consciousness subscales compared with myomectomy patients. When stratified by surgical route, these two subscale findings were similar between minimally invasive hysterectomy and minimally invasive myomectomy. Symptom severity scores did not differ after abdominal myomectomy compared with abdominal hysterectomy, but subscale scores on activity and energy/mood were higher with myomectomy. CONCLUSION: Both hysterectomy and myomectomy were associated with substantial improvement in HRQOL at short-term follow-up, with small but statistically significant differences in symptom severity and certain subscales. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02260752.

Vaccination Trends in Patients With Heart Failure: Insights From Get With The Guidelines-Heart Failure.

OBJECTIVES: This study sought to evaluate and contribute to the limited data on U.S. hospital practice patterns with respect to respiratory vaccination in patients hospitalized with heart failure (HF). BACKGROUND: Respiratory infection is a major driver of morbidity in patients with HF, and many influenza and pneumococcal infections may be prevented by vaccination. METHODS: This study evaluated patients hospitalized at centers participating in the Get With The Guidelines-HF (GWTG-HF) registry from October 2012 to March 2017. The proportion of patients receiving vaccination was described for influenza and pneumococcal vaccination, respectively. The association of hospital-level vaccination rates with individual GWTG-HF performance measures and defect-free care was evaluated using multivariable modeling. RESULTS: This study evaluated 313,761 patients discharged from 392 hospitals during the study period. The proportion of patients receiving influenza vaccination was 68% overall and declined from 70% in 2012 to 2013 to 66% in 2016 to 2017 (p < 0.001), although this was not statistically significant after adjustment (odds ratio: 1.05 per flu season; 95% confidence interval [CI]: 0.94 to 1.18). The proportion of patients receiving pneumococcal vaccination was 66% overall and decreased over the study period from 71% in 2013 to 60% in 2016 (p < 0.001), remaining significant after adjustment (odds ratio: 0.75 per calendar year; 95% CI: 0.67 to 0.84). Hospitals with higher vaccination rates were more likely to discharge patients with higher performance on defect-free care and individual GWTG-HF performance measures (p < 0.001). In a subset of patients with linked Medicare claims, vaccinated patients had similar rates of 1-year all-cause mortality (adjusted hazard ratio: 0.96 [95% CI: 0.89 to 1.03] for influenza vaccination; adjusted hazard ratio: 0.95 [95% CI: 0.89 to 1.01] for pneumococcal vaccination) compared with those not vaccinated. CONCLUSIONS: Nearly 1 in 3 patients hospitalized with HF at participating hospitals were not vaccinated for influenza or pneumococcal pneumonia, and vaccination rates did not improve from 2012 to 2017. Hospitals that exhibited higher vaccination rates performed well with respect to other HF quality of care measures. Vaccination status was not associated with differences in clinical outcomes. Further randomized controlled data are needed to assess the relationship between vaccination and outcomes.

The Comparing Options for Management: PAtient-centered REsults for Uterine Fibroids (COMPARE-UF) registry: rationale and design.

BACKGROUND: Uterine fibroids are common in premenopausal women, yet comparative effectiveness research on uterine fibroid treatments is rare. OBJECTIVE: The purpose of this study was to design and establish a uterine fibroid registry based in the United States to provide comparative effectiveness data regarding uterine fibroid treatment. STUDY DESIGN: We report here the design and initial recruitment for the Comparing Options for Management: Patient-centered REsults for Uterine Fibroids (COMPARE-UF) registry (Clinicaltrials.gov, NCT02260752), funded by the Agency for Healthcare Research and Quality in collaboration with the Patient-Centered Outcomes Research Institute. COMPARE-UF was designed to help answer critical questions about treatment options for women with symptomatic uterine fibroids. Women who undergo a procedure for uterine fibroids (hysterectomy, myomectomy [abdominal, hysteroscopic, vaginal, and laparoscopic/robotic], endometrial ablation, radiofrequency fibroid ablation, uterine artery embolization, magnetic resonance-guided focused ultrasound, or progestin-releasing intrauterine device insertion) at 1 of the COMPARE-UF sites are invited to participate in a prospective registry with 3 years follow up for postprocedural outcomes. Enrolled participants provide annual follow-up evaluation through an online portal or through traditional phone contact. A central data abstraction center provides information obtained from imaging, operative or procedural notes, and pathology reports. Women with uterine fibroids and other stakeholders are a key part of the COMPARE-UF registry and participate at all points from study design to dissemination of results. RESULTS: We built a network of 9 clinical sites across the United States with expertise in the care of women with uterine fibroids to capture geographic, racial, ethnic, and procedural diversity. Of the initial 2031 women who were enrolled in COMPARE-UF, 42% are self-identified as black or African American, and 40% are ≤40 years old, with 16% of participants <35 years old. Women who undergo myomectomy comprise the largest treatment group at 46% of all procedures, with laparoscopic or robotic myomectomy comprising the largest subset of myomectomies at 19% of all procedures. Hysterectomy is the second most common treatment within the registry at 38%. CONCLUSION: In response to priorities that were identified by our patient stakeholders, the initial aims within COMPARE-UF will address how different procedures that are used to treat uterine fibroids compare in terms of long-lasting symptom relief, potential for recurrence, medical complications, improvement in quality of life and sexual function, age at menopause, and fertility and pregnancy outcomes. COMPARE-UF will generate evidence on the comparative effectiveness of different procedural options for uterine fibroids and help patients and their caregivers make informed decisions that best meet an individual patient's short- and long-term preferences. Building on this infrastructure, the COMPARE-UF team of investigators and stakeholders, including patients, collaborate to identify future priorities for expanding the registry, such as assessing the efficacy of medical therapies for uterine fibroids. COMPARE-UF results will be disseminated directly to patients, providers, and other stakeholders by traditional academic pathways and by innovative methods that include a variety of social media platforms. Given demographic differences among women who undergo different uterine fibroid treatments, the assessment of comparative effectiveness for this disease through clinical trials will remain difficult. Therefore, this registry provides optimized evidence to help patients and their providers better understand the pros and cons of different treatment options so that they can make more informed decisions.

Regional Variation in 30-Day Ischemic Stroke Outcomes for Medicare Beneficiaries Treated in Get With The Guidelines-Stroke Hospitals.

BACKGROUND: We explored regional variation in 30-day ischemic stroke mortality and readmission rates and the extent to which regional differences in patients, hospitals, healthcare resources, and a quality of care composite care measure explain the observed variation. METHODS AND RESULTS: This ecological analysis aggregated patient and hospital characteristics from the Get With The Guidelines-Stroke registry (2007-2011), healthcare resource data from the Dartmouth Atlas of Health Care (2006), and Medicare fee-for-service data on 30-day mortality and readmissions (2007-2011) to the hospital referral region (HRR) level. We used linear regression to estimate adjusted HRR-level 30-day outcomes, to identify HRR-level characteristics associated with 30-day outcomes, and to describe which characteristics explained variation in 30-day outcomes. The mean adjusted HRR-level 30-day mortality and readmission rates were 10.3% (SD=1.1%) and 13.1% (SD=1.1%), respectively; a modest, negative correlation (r=-0.17; P=0.003) was found between one another. Demographics explained more variation in readmissions than mortality (25% versus 6%), but after accounting for demographics, comorbidities accounted for more variation in mortality compared with readmission rates (17% versus 7%). The combination of hospital characteristics and healthcare resources explained 11% and 16% of the variance in mortality and readmission rates, beyond patient characteristics. Most of the regional variation in mortality (65%) and readmission (50%) rates remained unexplained. CONCLUSIONS: Thirty-day mortality and readmission rates vary substantially across HRRs and exhibit an inverse relationship. While regional variation in 30-day outcomes were explained by patient and hospital factors differently, much of the regional variation in both outcomes remains unexplained.

Early transition to comfort measures only in acute stroke patients: Analysis from the Get With The Guidelines-Stroke registry.

BACKGROUND: Death after acute stroke often occurs after forgoing life-sustaining interventions. We sought to determine the patient and hospital characteristics associated with an early decision to transition to comfort measures only (CMO) after ischemic stroke (IS), intracerebral hemorrhage (ICH), and subarachnoid hemorrhage (SAH) in the Get With The Guidelines-Stroke registry. METHODS: We identified patients with IS, ICH, or SAH between November 2009 and September 2013 who met study criteria. Early CMO was defined as the withdrawal of life-sustaining treatments and interventions by hospital day 0 or 1. Using multivariable logistic regression, we identified patient and hospital factors associated with an early (by hospital day 0 or 1) CMO order. RESULTS: Among 963,525 patients from 1,675 hospitals, 54,794 (5.6%) had an early CMO order (IS: 3.0%; ICH: 19.4%; SAH: 13.1%). Early CMO use varied widely by hospital (range 0.6%-37.6% overall) and declined over time (from 6.1% in 2009 to 5.4% in 2013; p < 0.001). In multivariable analysis, older age, female sex, white race, Medicaid and self-pay/no insurance, arrival by ambulance, arrival off-hours, baseline nonambulatory status, and stroke type were independently associated with early CMO use (vs no early CMO). The correlation between hospital-level risk-adjusted mortality and the use of early CMO was stronger for SAH (r = 0.52) and ICH (r = 0.50) than AIS (r = 0.15) patients. CONCLUSIONS: Early CMO was utilized in about 5% of stroke patients, being more common in ICH and SAH than IS. Early CMO use varies widely between hospitals and is influenced by patient and hospital characteristics.

Association of Preceding Antithrombotic Treatment With Acute Ischemic Stroke Severity and In-Hospital Outcomes Among Patients With Atrial Fibrillation.

Importance: Antithrombotic therapies are known to prevent stroke for patients with atrial fibrillation (AF) but are often underused in community practice. Objectives: To examine the prevalence of patients with acute ischemic stroke with known history of AF who were not receiving guideline-recommended antithrombotic treatment before stroke and to determine the association of preceding antithrombotic therapy with stroke severity and in-hospital outcomes. Design, Setting, and Participants: Retrospective observational study of 94 474 patients with acute ischemic stroke and known history of AF admitted from October 2012 through March 2015 to 1622 hospitals participating in the Get With the Guidelines-Stroke program. Exposures: Antithrombotic therapy before stroke. Main Outcomes and Measures: Stroke severity as measured by the National Institutes of Health Stroke Scale (NIHSS; range of 0-42, with a higher score indicating greater stroke severity and a score ≥16 indicating moderate or severe stroke), and in-hospital mortality. Results: Of 94 474 patients (mean [SD] age, 79.9 [11.0] years; 57.0% women), 7176 (7.6%) were receiving therapeutic warfarin (international normalized ratio [INR] ≥2) and 8290 (8.8%) were receiving non-vitamin K antagonist oral anticoagulants (NOACs) preceding the stroke. A total of 79 008 patients (83.6%) were not receiving therapeutic anticoagulation; 12 751 (13.5%) had subtherapeutic warfarin anticoagulation (INR <2) at the time of stroke, 37 674 (39.9%) were receiving antiplatelet therapy only, and 28 583 (30.3%) were not receiving any antithrombotic treatment. Among 91 155 high-risk patients (prestroke CHA2DS2-VASc score ≥2), 76 071 (83.5%) were not receiving therapeutic warfarin or NOACs before stroke. The unadjusted rates of moderate or severe stroke were lower among patients receiving therapeutic warfarin (15.8% [95% CI, 14.8%-16.7%]) and NOACs (17.5% [95% CI, 16.6%-18.4%]) than among those receiving no antithrombotic therapy (27.1% [95% CI, 26.6%-27.7%]), antiplatelet therapy only (24.8% [95% CI, 24.3%-25.3%]), or subtherapeutic warfarin (25.8% [95% CI, 25.0%-26.6%]); unadjusted rates of in-hospital mortality also were lower for those receiving therapeutic warfarin (6.4% [95% CI, 5.8%-7.0%]) and NOACs (6.3% [95% CI, 5.7%-6.8%]) compared with those receiving no antithrombotic therapy (9.3% [95% CI, 8.9%-9.6%]), antiplatelet therapy only (8.1% [95% CI, 7.8%-8.3%]), or subtherapeutic warfarin (8.8% [95% CI, 8.3%-9.3%]). After adjusting for potential confounders, compared with no antithrombotic treatment, preceding use of therapeutic warfarin, NOACs, or antiplatelet therapy was associated with lower odds of moderate or severe stroke (adjusted odds ratio [95% CI], 0.56 [0.51-0.60], 0.65 [0.61-0.71], and 0.88 [0.84-0.92], respectively) and in-hospital mortality (adjusted odds ratio [95% CI], 0.75 [0.67-0.85], 0.79 [0.72-0.88], and 0.83 [0.78-0.88], respectively). Conclusions and Relevance: Among patients with atrial fibrillation who had experienced an acute ischemic stroke, inadequate therapeutic anticoagulation preceding the stroke was prevalent. Therapeutic anticoagulation was associated with lower odds of moderate or severe stroke and lower odds of in-hospital mortality.

Use of Strategies to Improve Door-to-Needle Times With Tissue-Type Plasminogen Activator in Acute Ischemic Stroke in Clinical Practice: Findings from Target: Stroke.

BACKGROUND: The implementation of Target: Stroke Phase I, the first stage of the American Heart Association's national quality improvement initiative to accelerate door-to-needle (DTN) times, was associated with an average 15-minute reduction in DTN times. TARGET: Stroke phase II was launched in April 2014 with a goal of promoting further reduction in treatment times for tissue-type plasminogen activator (tPA) administration. METHODS AND RESULTS: We conducted a second survey of Get With The Guidelines-Stroke hospitals regarding strategies used to reduce delays after Target: Stroke and quantify their association with DTN times. A total of 16 901 ischemic stroke patients were treated with intravenous tPA within 4.5 hours of symptom onset from 888 surveyed hospitals between June 2014 and April 2015. The patient-level median DTN time was 56 minutes (interquartile range, 42-75), with 59.3% of patients receiving intravenous tPA within 60 minutes and 30.4% within 45 minutes after hospital arrival. Most hospitals reported routinely using a majority of Target: Stroke key practice strategies, although direct transport of patients to computed tomographic/magenetic resonance imaging scanner, premix of tPA ahead of time, initiation of tPA in brain imaging suite, and prompt data feedback to emergency medical services providers were used less frequently. Overall, we identified 16 strategies associated with significant reductions in DTN times. Combined, a total of 20 minutes (95% confidence intervals 15-25 minutes) could be saved if all strategies were implemented. CONCLUSIONS: Get With The Guidelines-Stroke hospitals have initiated a majority of Target: Stroke-recommended strategies to reduce DTN times in acute ischemic stroke. Nevertheless, certain strategies were infrequently practiced and represent a potential immediate target for further improvements.