Sudden Cardiac Death or Ventricular Arrythmia in Patients Taking Levetiracetam or Oxcarbazepine.

BACKGROUND AND OBJECTIVES: Levetiracetam is a widely used antiseizure medication. Recent concerns have been raised regarding the potential prolongation of the QT interval by levetiracetam and increased risk of sudden cardiac death. This could have profound implications for patient safety and for prescribing practice. This study assessed the potential association of levetiracetam with cardiac outcomes related to QT interval prolongation. We compared outcomes of patients taking levetiracetam with those taking oxcarbazepine as a comparator medication that has not been associated with prolongation of the QT interval. METHODS: The sample included patients who were newly prescribed levetiracetam or oxcarbazepine from January 31, 2010, to December 31, 2019, using administrative claims data from the OptumLabs Data Warehouse (OLDW). The analysis focused on a combined endpoint of sudden cardiac death or ventricular arrythmia, which are both linked to QT interval prolongation. We used a new user design and selected oxcarbazepine as an active comparator with levetiracetam to minimize bias. We used propensity score weighting to balance the levetiracetam and oxcarbazepine cohorts and then performed weighted Cox regressions to evaluate the association of levetiracetam with the combined endpoint. RESULTS: We identified 104,655 enrollees taking levetiracetam and 39,596 enrollees taking oxcarbazepine. At baseline, enrollees taking levetiracetam were older, more likely to have diagnosed epilepsy, and more likely to have diagnosed comorbidities including hypertension, cerebrovascular disease, and coronary artery disease. In the main analysis, we found no significant difference between levetiracetam and oxcarbazepine in the rate of the combined endpoint for the Cox proportional hazards model (hazard ratio [HR] 0.79, 95% CI 0.42-1.47) or Cox regression with time-varying characteristics (HR 0.78, 95% CI 0.41-1.50). DISCUSSION: When compared with oxcarbazepine, levetiracetam does not correlate with increased risk of ventricular arrythmia and sudden cardiac death. Our finding does not support the concern for cardiac risk to indicate restriction of levetiracetam use nor the requirement of cardiac monitoring when using it. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that sudden cardiac death and ventricular arrythmia are not more frequent in patients older than 17 years newly prescribed levetiracetam, compared with those prescribed oxcarbazepine.

Approval, Evidence, and "Off-Label" Device Utilization: The Patent Foramen Ovale Closure Story.

BACKGROUND: Following regulatory approval, medical devices may be used "off-label." Patent foramen ovale (PFO) closure is indicated to reduce recurrent stroke but has been proposed for other indications, including migraine, transient ischemic attack, and diving decompression illness. We sought to evaluate PFO closure rates and indications relative to the timing of regulatory approval and publication of key randomized trials. METHODS: We performed a retrospective cohort study using the OptumLabs Data Warehouse of US commercial insurance enrollees from 2006 to 2019. We quantified PFO closure among individuals with ≥2 years of preprocedure coverage to establish indications, classified hierarchically as stroke/systemic embolism, migraine, transient ischemia attack, or other. RESULTS: We identified 5315 patients undergoing PFO closure (51.8% female, 29.2%≥60 years old), which increased from 4.75 per 100 000 person-years in 2006 to 6.60 per 100 000 person-years in 2019. Patients aged ≥60 years accounted for 29.2% of closures. Procedure volumes corresponded weakly with supportive clinical publications and device approval. Among patients with PFO closure, 58.6% underwent closure for stroke/systemic embolism, 10.2% for transient ischemia attack, 8.8% for migraine, and 22.4% for other indications; 17.6% of patients had atrial fibrillation at baseline; and 11.9% developed atrial fibrillation postprocedure. Those aged ≥60 years and male were less likely to undergo closure for migraine than stroke/systemic embolism. CONCLUSIONS: From 2006 to 2019, PFO closure use was consistently low and corresponded weakly with clinical trial publications and regulatory status. Nearly half of patients underwent PFO closure for indications unapproved by the Food and Drug Administration. Regulators and payers should coordinate mechanisms to promote utilization for approved indications to ensure patient safety and should facilitate clinical trials for other possible indications.

Race-ethnicity and sex differences in 1-year survival following percutaneous coronary intervention among Medicare fee-for-service beneficiaries.

RATIONALE: Existing literature describing differences in survival following percutaneous coronary intervention (PCI) by patient sex, race-ethnicity and the role of socioeconomic characteristics (SEC) is limited. AIMS AND OBJECTIVES: Evaluate differences in 1-year survival after PCI by sex and race-ethnicity, and explore the contribution of SEC to observed differences. METHODS: Using a 20% sample of Medicare claims data for beneficiaries aged 65+, we identified fee-for-service patients who received PCI from 2007 to 2015. We performed logistic regression to assess how sex and race-ethnicity relate to procedural indication, inpatient versus outpatient setting, and 1-year mortality. We evaluated whether these relationships are moderated by sequentially controlling for factors including age, comorbidities, presence of acute myocardial infarction (AMI), county SEC, medical resource availability and inpatient versus outpatient procedural status. RESULTS: We identified 300,491 PCI procedures, of which 94,863 (31.6%) were outpatient. There was a significant transition to outpatient PCI during the study period, especially for men compared with women and White patients compared with Black patients. Black patients were 3.50 percentage points (p < 0.001) and women were 3.41 percentage points (p < 0.001) more likely than White and male patients to undergo PCI at the time of AMI, which typically occurs in the inpatient setting. Controlling for age and calendar year, Black patients were 2.87 percentage points more likely than non-Hispanic White patients to die within 1 year after PCI. After controlling for Black-White differences in comorbidities, the differences in 1-year mortality decreased to 0.95 percentage points, which then became nonsignificant when further controlling for county resources and state of residence. CONCLUSION: Women were more likely to experience PCI in the setting of AMI and had less transition to outpatient care during the period. Black patients experienced higher 1-year mortality following PCI, which is explained by differences in baseline comorbidities, county medical resources, and state of residence.

Evaluation of the Predictive Value of Routinely Collected Health-Related Social Needs Measures.

The objective was to assess the value of routinely collected patient-reported health-related social needs (HRSNs) measures for predicting utilization and health outcomes. The authors identified Mayo Clinic patients with cancer, diabetes, or heart failure. The HRSN measures were collected as part of patient-reported screenings from June to December 2019 and outcomes (hospitalization, 30-day readmission, and death) were ascertained in 2020. For each outcome and disease combination, 4 models were used: gradient boosting machine (GBM), random forest (RF), generalized linear model (GLM), and elastic net (EN). Other predictors included clinical factors, demographics, and area-based HRSN measures-area deprivation index (ADI) and rurality. Predictive performance for models was evaluated with and without the routinely collected HRSN measures as change in area under the curve (AUC). Variable importance was also assessed. The differences in AUC were mixed. Significant improvements existed in 3 models of death for cancer (GBM: 0.0421, RF: 0.0496, EN: 0.0428), 3 models of hospitalization (GBM: 0.0372, RF: 0.0640, EN: 0.0441), and 1 of death (RF: 0.0754) for diabetes, and 1 model of readmissions (GBM: 0.1817), and 3 models of death (GBM: 0.0333, RF: 0.0519, GLM: 0.0489) for heart failure. Age, ADI, and the Charlson comorbidity index were the top 3 in variable importance and were consistently more important than routinely collected HRSN measures. The addition of routinely collected HRSN measures resulted in mixed improvement in the predictive performance of the models. These findings suggest that existing factors and the ADI are more important for prediction in these contexts. More work is needed to identify predictors that consistently improve model performance.

Evaluation of safety and care outcomes after the introduction of a virtual registered nurse model.

OBJECTIVE: To evaluate the impact of a virtual registered nurse (ViRN) model on safety and care outcomes. ViRN is a telemedicine intervention that enables an experienced virtual nurse to assist the in-person care team in providing care to patients. DATA SOURCES AND STUDY SETTING: Electronic health records data were utilized from the Mayo Clinic during the intervention (December 2020-November 2021) and historical periods (December 2018-November 2019). ViRN was implemented on general medical units at the Mayo Clinic Rochester. We used general medical units at the Mayo Clinic Arizona as the comparison group. STUDY DESIGN: This study used a difference-in-differences design to evaluate the impact of ViRN compared to usual care on transfer to the intensive care unit (ICU), inpatient mortality, and length of stay (LOS). We used logistic regression for transfer to the ICU and inpatient mortality and negative binomial regression for LOS. We controlled for demographics, patient interaction with the health system, clinical characteristics, and admission characteristics. We clustered standard errors to account for patients who have multiple admissions during the study period. PRINCIPAL FINDINGS: There were no significant differences for transfer to the ICU (average marginal effect (AME) -0.08 percentage point [95% confidence interval (CI): -1.34, 1.18]), inpatient mortality (AME 0.43 percentage point [95% CI: -0.33, 1.18]), or LOS (AME -0.20 days [95% CI: -0.57, 0.17]). The findings were mostly consistent across the sensitivity analyses. CONCLUSIONS: Our results suggest that ViRN led to similar outcomes as usual care in general medical units. These findings support the potential to develop more advanced models of ViRN at the Mayo Clinic and the dissemination of the ViRN model to other systems. In the context of staffing shortages and other disruptions to the delivery of nursing care, it is critical to understand whether new models like ViRN provide nurse staffing alternatives without negatively affecting outcomes.

National trends in emergency conditions through the Omicron COVID-19 wave in commercial and Medicare Advantage enrollees.

Objective: To evaluate trends in emergency care sensitive conditions (ECSCs) from pre-COVID (March 2018-February 2020) through Omicron (December 2021-February 2022). Methods: This cross-sectional analysis evaluated trends in ECSCs using claims (OptumLabs Data Warehouse) from commercial and Medicare Advantage enrollees. Emergency department (ED) visits for ECSCs (acute appendicitis, aortic aneurysm/dissection, cardiac arrest/severe arrhythmia, cerebral infarction, myocardial infarction, pulmonary embolism, opioid overdose, pre-eclampsia) were reported per 100,000 person months from March 2018 to February 2022 by pandemic wave. We calculated the percent change for each pandemic wave compared to the pre-pandemic period. Results: There were 10,268,554 ED visits (March 2018-February 2022). The greatest increases in ECSCs were seen for pulmonary embolism, cardiac arrest/severe arrhythmia, myocardial infarction, and pre-eclampsia. For commercial enrollees, pulmonary embolism visit rates increased 22.7% (95% confidence interval [CI], 18.6%-26.9%) during Waves 2-3, 37.2% (95% CI, 29.1%-45.8%] during Delta, and 27.9% (95% CI, 20.3%-36.1%) during Omicron, relative to pre-pandemic rates. Cardiac arrest/severe arrhythmia visit rates increased 4.0% (95% CI, 0.2%-8.0%) during Waves 2-3; myocardial infarction rates increased 4.9% (95% CI, 2.1%-7.8%) during Waves 2-3. Similar patterns were seen in Medicare Advantage enrollees. Pre-eclampsia visit rates among reproductive-age female enrollees increased 31.1% (95% CI, 20.9%-42.2%), 23.7% (95% CI, 7.5%,-42.3%), and 34.7% (95% CI, 16.8%-55.2%) during Waves 2-3, Delta, and Omicron, respectively. ED visits for other ECSCs declined or exhibited smaller increases. Conclusions: ED visit rates for acute cardiovascular conditions, pulmonary embolism and pre-eclampsia increased despite declines or stable rates for all-cause ED visits and ED visits for other conditions. Given the changing landscape of ECSCs, studies should identify drivers for these changes and interventions to mitigate them.

Advanced Heart Failure Characteristics and Outcomes in Commercially Insured U.S. Adults.

BACKGROUND: The characteristics and outcomes of patients with advanced heart failure (HF) have been poorly defined due to challenges in applying the complex advanced HF definition broadly to populations. OBJECTIVES: In this study, the authors sought to apply a validated advanced HF algorithm to a large U.S. administrative claims database and describe the population and use of advanced HF therapies. METHODS: This study included adults with advanced HF identified in the OptumLabs Data Warehouse from 2009 to 2019. The algorithm for advanced HF required 2 hospitalizations for HF plus 1 additional sign of advanced HF in a 12-month period. The association of baseline characteristics with mortality was examined with the use of Cox proportional hazards models. Associations of patient characteristics with advanced therapies were estimated with the use of cause-specific Cox proportional hazard models. RESULTS: In 60,197 patients identified with advanced HF, the mean age was 73 years, 51.5% were men, and 64.3% were non-Hispanic White, 1.9% Asian, 21.2% Black, and 8.2% Hispanic. The median survival with advanced HF was 2.0 years (IQR: 0.4-5.5 years). Differences in mortality and use of advanced therapies by age, sex, and race/ethnicity were observed. Adjusted mortality was higher in patients who were older, male, non-Hispanic White, and from rural areas (P < 0.05 for all). Advanced therapies were used less in older patients and women (P < 0.05 for both). Black patients were more likely to be treated with a left ventricular assist device (P = 0.010) but less likely to receive a heart transplant compared with White patients (P = 0.034). CONCLUSIONS: In U.S. adults with advanced HF, variation in outcomes and use of advanced therapies exist by age, sex, and race/ethnicity.

Association between early childhood sleep difficulties and subsequent psychiatric illness.

STUDY OBJECTIVES: Chronic disruptions to sleep in childhood are associated with increased prevalence of psychiatric disease later in development. When sleep disruptions remit before adolescence, the increased prevalence of psychiatric disease is no longer observed, highlighting the importance of early detection and intervention. Clinicians typically rely on caregivers' reports for diagnosis and management of childhood sleep challenges. We examined whether findings on polysomnogram (PSG) can offer similar insight into childhood sleep difficulties and the risk of subsequent psychiatric illness. METHODS: A cohort was identified of 348 children ages 5 years 11 months and younger with sleep difficulties rising to the level of formal clinical workup. A retrospective review of caregiver-reported sleep concerns, PSG results, and subsequent psychiatric illness was completed. PSG findings were compared to presence of psychiatric illness later in life as well as caregivers' reported concerns. Chi-squared and Fisher's exact tests were completed to evaluate correlations and Cohen's kappa was used to evaluate agreement. RESULTS: With only a few exceptions, comparisons between clinician findings on PSG and subsequent psychiatric diagnoses were statistically nonsignificant. Similarly, the relationship between caregivers' subjective reports about sleep and clinicians' findings on PSG demonstrated only slight to fair agreement, suggesting reported concerns were not predictive of PSG results. CONCLUSIONS: Parental reports of subjective sleep concerns are indicative of different sleep pathologies compared to sleep pathologies detected on PSG. The addition of PSG to caregiver-reported data appears to have limited clinical utility in understanding sleep concerns associated with the risk of subsequent psychiatric illness in young children. CITATION: Pease E, Shekunov J, Savitz ST, et al. Association between early childhood sleep difficulties and subsequent psychiatric illness. J Clin Sleep Med. 2023;19(12):2059-2063.

Co-Occurrence of Social Risk Factors and Associated Outcomes in Patients With Heart Failure.

Background Among patients with heart failure (HF), social risk factors (SRFs) are associated with poor outcomes. However, less is known about how co-occurrence of SRFs affect all-cause health care utilization for patients with HF. The objective was to address this gap using a novel approach to classify co-occurrence of SRFs. Methods and Results This was a cohort study of residents living in an 11-county region of southeast Minnesota, aged ≥18 years with a first-ever diagnosis for HF between January 2013 and June 2017. SRFs, including education, health literacy, social isolation, and race and ethnicity, were obtained via surveys. Area-deprivation index and rural-urban commuting area codes were determined from patient addresses. Associations between SRFs and outcomes (emergency department visits and hospitalizations) were assessed using Andersen-Gill models. Latent class analysis was used to identify subgroups of SRFs; associations with outcomes were examined. A total of 3142 patients with HF (mean age, 73.4 years; 45% women) had SRF data available. The SRFs with the strongest association with hospitalizations were education, social isolation, and area-deprivation index. We identified 4 groups using latent class analysis, with group 3, characterized by more SRFs, at increased risk of emergency department visits (hazard ratio [HR], 1.33 [95% CI, 1.23-1.45]) and hospitalizations (HR, 1.42 [95% CI, 1.28-1.58]). Conclusions Low educational attainment, high social isolation, and high area-deprivation index had the strongest associations. We identified meaningful subgroups with respect to SRFs, and these subgroups were associated with outcomes. These findings suggest that it is possible to apply latent class analysis to better understand the co-occurrence of SRFs among patients with HF.

Study What You Do: Developing a Psychotherapy Tracking Database in a Large-Scale Integrated Behavioral Health Service.

PURPOSE: Many individuals with behavioral health challenges receive services in primary care, and integrated behavioral health (IBH) programs can help increase access to evidence-based interventions. IBH programs can benefit substantially from integrating standardized tracking databases that allow for the implementation of measurement-based care to evaluate patient-, clinician-, and practice-level outcomes. We describe the development and integration of Mayo Clinic's pediatric and adult primary care psychotherapy tracking database. METHODS: IBH practice leaders directed the development of a large psychotherapy tracking database that continuously populates from Mayo Clinic's electronic health record system. The database captures numerous patient variables including demographics, behavioral health and substance use issues, psychotherapy principles used, and self-reported symptoms. We retrieved current data for patients empaneled in Mayo Clinic's pediatric and adult primary care psychotherapy programs from June 2014 to June 2022. RESULTS: The tracking database contained data for 16,923 adult patients and 6,298 pediatric patients. The mean age of adult patients was 43.2 years (SD 18.3), 88.1% were non-Latine White, and 66.7% identified as female. The mean age of pediatric patients was 11.6 years (SD 4.2), 82.5% were non-Latine White, and 56.9% identified as female. We provide examples of practical applications of the database across clinical, educational, research, and administrative domains. CONCLUSIONS: The development and integration of a psychotherapy tracking database supports clinician communication, examination of patient outcomes, practice quality improvement efforts, and clinically relevant research. Our description of Mayo Clinic's IBH database may serve as a model for other IBH practices.

Predicting short-term outcomes after transcatheter aortic valve replacement for aortic stenosis.

BACKGROUND: The approved use of transcatheter aortic valve replacement (TAVR) for aortic stenosis has expanded substantially over time. However, gaps remain with respect to accurately delineating risk for poor clinical and patient-centered outcomes. Our objective was to develop prediction models for 30-day clinical and patient-centered outcomes after TAVR within a large, diverse community-based population. METHODS: We identified all adults who underwent TAVR between 2013-2019 at Kaiser Permanente Northern California, an integrated healthcare delivery system, and were monitored for the following 30-day outcomes: all-cause death, improvement in quality of life, all-cause hospitalizations, all-cause emergency department (ED) visits, heart failure (HF)-related hospitalizations, and HF-related ED visits. We developed prediction models using gradient boosting machines using linked demographic, clinical and other data from the Society for Thoracic Surgeons (STS)/American College of Cardiology (ACC) TVT Registry and electronic health records. We evaluated model performance using area under the curve (AUC) for model discrimination and associated calibration plots. We also evaluated the association of individual predictors with outcomes using logistic regression for quality of life and Cox proportional hazards regression for all other outcomes. RESULTS: We identified 1,565 eligible patients who received TAVR. The risks of adverse 30-day post-TAVR outcomes ranged from 1.3% (HF hospitalizations) to 15.3% (all-cause ED visits). In models with the highest discrimination, discrimination was only moderate for death (AUC 0.60) and quality of life (AUC 0.62), but better for HF-related ED visits (AUC 0.76). Calibration also varied for different outcomes. Importantly, STS risk score only independently predicted death and all-cause hospitalization but no other outcomes. Older age also only independently predicted HF-related ED visits, and race/ethnicity was not significantly associated with any outcomes. CONCLUSIONS: Despite using a combination of detailed STS/ACC TVT Registry and electronic health record data, predicting short-term clinical and patient-centered outcomes after TAVR remains challenging. More work is needed to identify more accurate predictors for post-TAVR outcomes to support personalized clinical decision making and monitoring strategies.

Identifying appropriate comparison groups for health system interventions in the COVID-19 era.

Introduction: COVID-19 has created additional challenges for the analysis of non-randomized interventions in health system settings. Our objective is to evaluate these challenges and identify lessons learned from the analysis of a medically tailored meals (MTM) intervention at Kaiser Permanente Northwest (KPNW) that began in April 2020. Methods: We identified both a historical and concurrent comparison group. The historical comparison group included patients living in the same area as the MTM recipients prior to COVID-19. The concurrent comparison group included patients admitted to contracted non-KPNW hospitals or admitted to a KPNW facility and living outside the service area for the intervention but otherwise eligible. We used two alternative propensity score methods in response to the loss of sample size with exact matching to evaluate the intervention. Results: We identified 452 patients who received the intervention, 3873 patients in the historical comparison group, and 5333 in the concurrent comparison group. We were able to mostly achieve balance on observable characteristics for the intervention and the two comparison groups. Conclusions: Lessons learned included: (a) The use of two different comparison groups helped to triangulate results; (b) the meaning of utilization measures changed pre- and post-COVID-19; and (c) that balance on observable characteristics can be achieved, especially when the comparison groups are meaningfully larger than the intervention group. These findings may inform the design for future evaluations of interventions during COVID-19.

Guideline-Directed Medical Therapy in Newly Diagnosed Heart Failure With Reduced Ejection Fraction in the Community.

BACKGROUND: Guideline-directed medical therapy (GDMT) dramatically improves outcomes in heart failure with reduced ejection fraction (HFrEF). Our goal was to examine GDMT use in community patients with newly diagnosed HFrEF. METHODS AND RESULTS: We performed a population-based, retrospective cohort study of all Olmsted County, Minnesota, residents with newly diagnosed HFrEF (EF ≤ 40%) 2007-2017. We excluded patients with contraindications to medication initiation. We examined the use of beta-blockers, HF beta-blockers (metoprolol succinate, carvedilol, bisoprolol), angiotensin converting enzyme inhibitors (ACEis), angiotensin receptor blockers (ARBs), angiotensin receptor neprilysin inhibitors (ARNIS), and mineralocorticoid receptor antagonists (MRAs) in the first year after HFrEF diagnosis. We used Cox models to evaluate the association of being seen in an HF clinic with the initiation of GDMT. From 2007 to 2017, 1160 patients were diagnosed with HFrEF (mean age 69.7 years, 65.6% men). Most eligible patients received beta-blockers (92.6%) and ACEis/ARBs/ARNIs (87.0%) in the first year. However, only 63.8% of patients were treated with an HF beta-blocker, and few received MRAs (17.6%). In models accounting for the role of an HF clinic in initiation of these medications, being seen in an HF clinic was independently associated with initiation of new GDMT across all medication classes, with a hazard ratio (95% CI) of 1.54 (1.15-2.06) for any beta-blocker, 2.49 (1.95-3.20) for HF beta-blockers, 1.97 (1.46-2.65) for ACEis/ARBs/ARNIs, and 2.14 (1.49-3.08) for MRAs. CONCLUSIONS: In this population-based study, most patients with newly diagnosed HFrEF received beta-blockers and ACEis/ARBs/ARNIs. GDMT use was higher in patients seen in an HF clinic, suggesting the potential benefit of referral to an HF clinic for patients with newly diagnosed HFrEF.

Association of Patient and System-Level Factors With Social Determinants of Health Screening.

BACKGROUND: Health systems are increasingly recognizing the importance of collecting social determinants of health (SDoH) data. However, gaps remain in our understanding of facilitators or barriers to collection. To address these gaps, we evaluated a real-world implementation of a SDoH screening tool. METHODS: We conducted a retrospective analysis of the implementation of the SDoH screening tool at Mayo Clinic in 2019. The outcomes are: (1) completion of screening and (2) the modality used (MyChart: filled out on patient portal; WelcomeTablet: filled out by patient on a PC-tablet; EpicCare: data obtained directly by provider and entered in chart). We conducted logistic regression for completion and multinomial logistic regression for modality. The factors of interest included race and ethnicity, use of an interpreter, and whether the visit was for primary care. RESULTS: Overall, 58.7% (293,668/499,931) of screenings were completed. Patients using interpreters and racial/ethnic minorities were less likely to complete the screening. Primary care visits were associated with an increase in completion compared with specialty care visits. Patients who used an interpreter, racial and ethnic minorities, and primary care visits were all associated with greater WelcomeTablet and lower MyChart use. CONCLUSION: Patient and system-level factors were associated with completion and modality. The lower completion and greater WelcomeTablet use among patients who use interpreters and racial and ethnic minorities points to the need to improve screening in these groups and that the availability of the WelcomeTablet may have prevented greater differences. The higher completion in primary care visits may mean more outreach is needed for specialists.

Coronary revascularization outcomes in relation to skilled nursing facility use following hospital discharge.

BACKGROUND: Observational analyses comparing coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI) among elderly or frail patients are likely biased by treatment selection. PCI is typically chosen for frail patients, while CABG is more common for patients with good recovery potential. HYPOTHESIS: We hypothesized that skilled nursing facility (SNF) use after revascularization is a measure of relative frailty associated with outcomes following coronary revascularization. METHODS: We used a 20 percent sample of Medicare beneficiaries aged 65 years or older who received inpatient PCI or CABG between 2007-2014. Key explanatory variables were the revascularization strategy and SNF use after revascularization. We used Cox regression to evaluate death and repeat revascularization within one year and logistic regression to evaluate SNF use and 30-day readmissions/death. RESULTS: CABG patients were 25.1 percentage points [95% confidence interval: 24.7, 25.5] more likely to use SNF following revascularization than inpatient PCI patients. SNF use was associated with a higher death rate (hazard ratio (HR): 3.19 [3.02, 3.37]) and a 16.2 percentage point (15.5, 16.9) increase in 30-day readmissions/death. Among patients with SNF use, CABG was associated with a decrease in 30-day readmissions/death compared to PCI. CONCLUSIONS: While CABG was associated with higher rates of SNF use and 30-day readmission/death overall, CABG was associated with significantly lower rates of 30-day readmissions/death among patients with SNF use. The findings suggest that caution is needed in treatment selection for patients at high-risk for SNF use and that selection of inpatient PCI over CABG may be associated with frailty and worse outcomes for some patients.

Contemporary Reevaluation of Race and Ethnicity With Outcomes in Heart Failure.

Background Variation in outcomes by race/ethnicity in adults with heart failure (HF) has been previously observed. Identifying factors contributing to these variations could help target interventions. We evaluated the association of race/ethnicity with HF outcomes and potentially contributing factors within a contemporary HF cohort. Methods and Results We identified members of Kaiser Permanente Northern California, a large integrated healthcare delivery system, who were diagnosed with HF between 2012 and 2016 and had at least 1 year of prior continuous membership and left ventricular ejection fraction data. We used Cox regression with time-dependent covariates to evaluate the association of self-identified race/ethnicity with HF or all-cause hospitalization and all-cause death, with backward selection for potential explanatory variables. Among 34 621 patients with HF, compared with White patients, Black patients had a higher rate of HF hospitalization (adjusted hazard ratio [HR], 1.28; 95% CI, 1.18-1.38) but a lower rate of death (adjusted HR, 0.78; 95% CI, 0.72-0.85). In contrast, Asian/Pacific Islander patients had similar rates of HF hospitalization, but lower rates of all-cause hospitalization (adjusted HR, 0.89; 95% CI, 0.85-0.93) and death (adjusted HR, 0.75; 95% CI, 0.69-0.80). Hispanic patients also had a lower rate of death (adjusted HR, 0.85; 95% CI, 0.80-0.91). Sensitivity analyses showed that effect sizes for Black patients were larger among patients with reduced ejection fraction. Conclusions In a contemporary and diverse population with HF, Black patients experienced a higher rate of HF hospitalization and a lower rate of death compared with White patients. In contrast, selected outcomes for Asian/Pacific Islander and Hispanic patients were more favorable compared with White patients. The observed differences were not explained by measured potentially modifiable factors, including pharmacological treatment. Future research is needed to identify explanatory mechanisms underlying ongoing racial/ethnic variation to target potential interventions.

How much can we trust electronic health record data?

Trust in EHR data is becoming increasingly important as a greater share of clinical and health services research use EHR data. We discuss reasons for distrust and acknowledge limitations. Researchers continue to use EHR data because of strengths including greater clinical detail than sources like administrative billing claims. Further, many limitations are addressable with existing methods including data quality checks and common data frameworks. We discuss how to build greater trust in the use of EHR data for research, including additional transparency and research priority areas that will both enhance existing strengths of the EHR and mitigate its limitations.

Treatment selection and medication adherence for stable angina: The role of area-based health literacy.

RATIONALE, AIMS, AND OBJECTIVES: Clinical studies show equivalent health outcomes from interventional procedures and treatment with medication only for stable angina patients. However, patients may be subject to overuse or access barriers for interventional procedures and may exhibit suboptimal adherence to medications. Our objective is to evaluate whether community-level health literacy is associated with treatment selection and medication adherence patterns. METHOD: The sample included Medicare fee-for-service beneficiaries (20% random sample) with stable angina in 2007-2013. We used an area-level health literacy variable because of the lack of an individual measure in claims. We measured the association between (a) area-based health literacy with treatment selection (medication only, percutaneous coronary intervention [PCI], or coronary artery bypass grafting (CABG) surgery) and (b) area-based health literacy with medication adherence. We controlled for other factors including demographics, co-morbidity burden, dual eligibility, and area deprivation index. RESULTS: We identified 8300 patients of whom 8.7% lived in a low health literacy area. Overall, 56% of patients received medication only, 28% received PCI, and 15% received CABG. Patients in low health literacy areas were less likely to receive CABG (-3.5 percentage points; 95% CI, -6.8 to -0.3) than were patients in high health literacy areas, but the significance was sensitive to specification. Overall, 81.5% and 71.5% of patients were adherent to antianginals and statins, respectively. Living in low health literacy areas was associated with lower adherence to antianginals (-3.3 percentage points; 95% CI, -6.1 to -0.6) but not statins. CONCLUSIONS: Low area-based health literacy was associated with being less likely to receive CABG and lower adherence, but the differences between low and high health literacy areas were small and sensitive to model specification. Individual factors such as dual eligibility status and race/ethnicity had stronger associations with outcomes than had area-based health literacy, suggesting that this area-based measure was inadequate to account for social determinants in this study.

Patient-Clinician Decision Making for Stable Angina: The Role of Health Literacy.

BACKGROUND: Stable angina patients have difficulty understanding the tradeoffs between treatment alternatives. In this analysis, we assessed treatment planning conversations for stable angina to determine whether inadequate health literacy acts as a barrier to communication that may partially explain this difficulty. METHODS: We conducted a descriptive analysis of patient questionnaire data from the PCI Choice Trial. The main outcomes were the responses to the Decisional Conflict Scale and the proportion of correct responses to knowledge questions about stable angina. We also conducted a qualitative analysis on recordings of patient-clinician discussions about treatment planning. The recordings were coded with the OPTION12 instrument for shared decision-making. Two analysts independently assessed the number and types of patient questions and expressions of preferences. RESULTS: Patient engagement did not differ by health literacy level and was generally low for all patients with respect to OPTION12 scores and the number of questions related to clinical aspects of treatment. Patients with inadequate health literacy had significantly higher decisional conflict. However, the proportion of knowledge questions answered correctly did not differ significantly by health literacy level. CONCLUSIONS: Patients with inadequate health literacy had greater decisional conflict but no difference in knowledge compared to patients with adequate health literacy. Inadequate health literacy may act as a barrier to communication, but gaps were found in patient engagement and knowledge for patients of all health literacy levels. The recorded patient-clinician encounters and the health literacy measure were valuable resources for conducting research on care delivery.