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Background Peripheral artery disease (PAD) is associated with modifiable atherosclerotic risk factors like hypertension, diabetes, hyperlipidemia, and smoking. However, the effect of risk factor control on outcomes and disparities in achieving control is less well understood. Methods All patients in an integrated, regional health system with PAD-related encounters, fee-for-service Medicare, and clinical risk factor control data were identified. Component risk factors were dichotomized into controlled and uncontrolled categories (control defined as low-density lipoprotein < 100 mg/dL, hemoglobin A1c < 7.0%, SBP < 140 mmHg, and current nonsmoker) and composite categories (none, 1, ⩾ 2 uncontrolled RFs) created. The primary outcome was major adverse vascular events (MAVE, a composite of all-cause mortality, myocardial infarction, stroke, and lower-extremity revascularization and amputation). Results The cohort included 781 patients with PAD, average age 72.5 ± 9.8 years, of whom 30.1% were Black, and 19.1% were Medicaid dual-enrolled. In this cohort, 260 (33.3%) had no uncontrolled risk factors and 200 (25.6%) had two or more uncontrolled risk factors. Patients with the poorest risk factor control were more likely to be Black ( p < 0.001), Medicaid dual-enrolled ( p < 0.001), and have chronic limb-threatening ischemia ( p = 0.009). Significant differences in MAVE by degree of risk factor control were observed at 30 days (none uncontrolled: 5.8%, 1 uncontrolled: 11.5%, ⩾ 2 uncontrolled: 13.6%; p = 0.01) but not at 1 year ( p = 0.08). risk factor control was not associated with outcomes at 1 year after adjustment for patient and PAD-specific characteristics. Conclusions risk factor control is poor among patients with PAD. Significant disparities in achieving optimal risk factor control represent a potential target for reducing inequities in outcomes.

BACKGROUND: Understanding the relationship between patterns of peripheral artery disease patterns and outcomes is an essential step towards improving care and outcomes. We hypothesized that clinician specialty would be associated with occurrence of major adverse vascular events (MAVE). METHODS: Patients with at least 1 peripheral artery disease-related encounter in our health system and fee-for-service Medicare were divided into groups based on the specialty of the clinician (cardiologist, surgeon, podiatrist, primary care, or other) providing a plurality of peripheral artery disease-coded care in the year prior to index encounter. The primary outcome was MAVE (a composite of all-cause mortality, myocardial infarction, stroke, lower extremity revascularization, and lower extremity amputation). RESULTS: The cohort included 1,768 patients, of whom 30.0% were Black, 23.9% were Medicaid dual-enrollment eligible, and 31.1% lived in rural areas. Patients receiving a plurality of their care from podiatrists had the highest 1-year rates of MAVE (34.4%, p

The authors sought to investigate associations between sacubitril/valsartan adherence and clinical outcomes after hospitalization for heart failure with reduced ejection fraction (HFrEF).Sacubitril/valsartan improves outcomes in HFrEF, though the extent to which medication adherence is associated with outcomes in routine care is less well characterized.The authors analyzed patients aged ≥65 years hospitalized for HFrEF within the Get With the Guidelines-Heart Failure registry linked with Medicare claims between October 2015 and September 2018 who were discharged with sacubitril/valsartan. Sacubitril/valsartan adherence was assessed using medication fills to calculate proportion of days covered (PDC) through 90 days postdischarge. Associations between postdischarge adherence (PDC or ≥80%) and risk of readmission and death within 1 year were examined by comparing cumulative incidences and adjusted event rates.Among 897 patients prescribed sacubitril/valsartan at discharge, 295 (32.9%) had PDC ≥80% and 602 (67.1%) had PDC 80%. Baseline characteristics were balanced between groups. Compared with patients with PDC 80%, patients with PDC ≥80% had a significantly lower adjusted hazard of all-cause rehospitalization (HR: 0.66 [95% CI: 0.48-0.89]) and death (HR: 0.42 [95% CI: 0.22-0.79]) at 90 days and at 1 year (HR: 0.69 [95% CI: 0.56-0.86] and HR: 0.53 [95% CI: 0.38-0.74], respectively). For every 5 percentage point increase in PDC, patients experienced a significant reduction in rehospitalization (HR: 0.98 [95% CI: 0.97-0.99]) and death (HR: 0.96 [95% CI: 0.94-0.97]) at 1 year.In patients hospitalized for HFrEF and discharged on sacubitril/valsartan, high adherence to sacubitril/valsartan within 90 days after discharge was associated with substantially lower rates of readmission and death. Additional efforts to improve adherence with sacubitril/valsartan and other guideline-directed medical therapies in HFrEF are warranted.

Background PAD increases the risk of cardiovascular mortality and limb loss, and disparities in treatment and outcomes have been described. However, the association of patient-specific characteristics with variation in outcomes is less well known. Methods Patients with PAD from Duke University Health System (DUHS) between January 1, 2015 and March 31, 2016 were identified. PAD status was confirmed through ground truth adjudication and predictive modeling using diagnosis codes, procedure codes, and other administrative data. Symptom severity, lower extremity imaging, and ankle-brachial index (ABI) were manually abstracted from the electronic health record (EHR). Data was linked to Centers for Medicare and Medicaid Services data to provide longitudinal follow up. Primary outcome was major adverse vascular events (MAVE), a composite of all-cause mortality, myocardial infarction (MI), stroke, lower extremity revascularization and amputation. Results Of 1,768 patients with PAD, 31.6% were asymptomatic, 41.2% had intermittent claudication (IC), and 27.3% had chronic limb-threatening ischemia (CLTI). At 1 year, patients with CLTI had higher rates of MAVE compared with asymptomatic or IC patients. CLTI and Medicaid dual eligibility were independent predictors of mortality. CLTI and Black race were associated with amputation. Conclusions Rates of MAVE were highest in patients with CLTI, but patients with IC or asymptomatic disease also had high rates of adverse events. Black and Medicaid dual-eligible patients were disproportionately present in the CLTI subgroup and were at higher risk of amputation and mortality, respectively. Future studies must focus on early identification of high-risk patient groups to improve outcomes in patients with PAD.

Background Sacubitril/Valsartan has been highly efficacious in randomized trials of heart failure with reduced ejection fraction (HFrEF). However, the effectiveness of sacubitril/valsartan in older patients hospitalized for HFrEF in real‐world US practice is unclear. Methods and Results This study included Medicare beneficiaries age ≥65 years who were hospitalized for HFrEF ≤40% in the Get With The Guidelines–Heart Failure registry between October 2015 and December 2018, and eligible for sacubitril/valsartan. Associations between discharge prescription of sacubitril/valsartan and clinical outcomes were assessed after inverse probability of treatment weighting and adjustment for other HFrEF medications. Overall, 1551 (10.9%) patients were discharged on sacubitril/valsartan. Of those not prescribed sacubitril/valsartan, 7857 (62.0%) were prescribed an angiotensin‐converting enzyme inhibitor/angiotensin II receptor blocker. Over 12‐month follow‐up, compared with a discharge prescription of angiotensin‐converting enzyme inhibitor/angiotensin II receptor blocker, sacubitril/valsartan was independently associated with lower all‐cause mortality (adjusted hazard ratio [HR], 0.82; 95% CI, 0.72–0.94; P =0.004) but not all‐cause hospitalization (adjusted HR, 0.97; 95% CI, 0.89–1.07; P =0.55) or heart failure hospitalization (adjusted HR, 1.04; 95% CI, 0.91–1.18; P =0.59). Patients prescribed sacubitril/valsartan versus those without a prescription had lower risk of all‐cause mortality (adjusted HR, 0.69; 95% CI, 0.60–0.79; P P =0.02), but not heart failure hospitalization (adjusted HR, 0.94; 95% CI, 0.82–1.08; P =0.40). Conclusions Among patients hospitalized for HFrEF, prescription of sacubitril/valsartan at discharge was independently associated with reduced postdischarge mortality compared with angiotensin‐converting enzyme inhibitor/angiotensin II receptor blocker, and reduced mortality and all‐cause hospitalization compared with no sacubitril/valsartan. These findings support the use of sacubitril/valsartan to improve postdischarge outcomes among older patients hospitalized for HFrEF in routine US clinical practice.

Background Sacubitril/valsartan has been highly efficacious in randomized clinical trials of patients with HFrEF. However, the effectiveness of sacubitril/valsartan in routine US clinical practice is unclear. Methods This study included patients age ≥65 years who were hospitalized for HFrEF (ejection fraction ≤40%), were eligible for sacubitril/valsartan at discharge, and were enrolled in the Get With The Guidelines-Heart Failure registry linked to Medicare claims between October 2015 and September 2017. Patients prescribed sacubitril/valsartan at discharge were compared with (1) patients not prescribed sacubitril/valsartan, and (2) patients prescribed ACEI/ARB at discharge. Study endpoints were post-discharge mortality and hospitalization outcomes at 12 months. Negative control (falsification) endpoints included hospitalization for urinary tract infection and hospitalization for nutritional disorder. To adjust for selection bias, inverse probability of treatment weighting and adjustment for other HFrEF medications prescribed at discharge were performed. Results Overall, 746 (8.1%) patients were discharged on sacubitril/valsartan and 8,466 (91.9%) were not. Of those not prescribed sacubitril/valsartan, 5,286 (62.4%) were prescribed an ACEI/ARB. As compared with no sacubitril/valsartan, discharge prescription of sacubitril/valsartan was independently associated with lower risk of all-cause mortality, all-cause hospitalization, and the composite of mortality or HF hospitalization at 12-month follow-up (Table). These findings were consistent in comparisons between sacubitril/valsartan and ACEI/ARB. Discharge sacubitril/valsartan prescription was not significantly associated with the negative control endpoints, suggesting the findings were unlikely due to residual confounding. Conclusions In this contemporary real-world population of US patients hospitalized for HFrEF and eligible for sacubitril/valsartan, prescription of sacubitril/valsartan at discharge was independently associated with substantial reductions in post-discharge mortality and hospitalization. These findings suggest that the significant benefits of sacubitril/valsartan observed in clinical trials extend to patients seen in routine US clinical practice.

We investigated associations between timing of sacubitril/valsartan initiation and postdischarge adherence among patients hospitalized for heart failure with reduced ejection fraction (HFrEF). Clinical trials support initiation of sacubitril/valsartan among patients hospitalized with HFrEF. The association between timing of initiation and postdischarge adherence is unknown.We analyzed patients hospitalized for HFrEF (EF of ≤40%) within the Get With The Guidelines Heart Failure registry linked with Medicare claims between October 2015 and September 2017 who were eligible for sacubitril/valsartan. Follow-up was through December 2018. Patients were grouped by timing of sacubitril/valsartan initiation. Sacubitril/valsartan adherence at 90 and 365 days after discharge was assessed by calculating proportion of days covered (PDC) using medication fills. Among 4666 patients, 108 (2.3%) were continued on sacubitril/valsartan (on sacubitril/valsartan at admission and discharge), 191 (4.1%) were initiated as inpatients, 130 (2.8%) were initiated at discharge, and 4237 (90.1%) were discharged without sacubitril/valsartan. Median (25th, 75th) proportion of days covered through 90 days among those continued, initiated as inpatients, and initiated at discharge was 0.9 (0.6-0.1), 0.3 (0.0-0.7), and 0.0 (0.0-0.7), respectively (P.001). Patients discharged without sacubitril/valsartan had very low rates of any sacubitril/valsartan fills within 90 and 365 days of discharge (2.1% and 7.7% of surviving patients, respectively).In 2015-2017 US clinical practice, more than 90% of eligible patients hospitalized for HFrEF were discharged without sacubitril/valsartan. Patients initiated as inpatients had a higher postdischarge proportion of days covered than patients initiated at discharge. Patients discharged without sacubitril/valsartan were unlikely to receive it during follow-up. These findings highlight the importance of initiating sacubitril/valsartan during hospitalization to improve the quality of care.

Background On May 20, 2016, US professional organizations in cardiology published joint treatment guidelines recommending the use of angiotensin-receptor neprilysin inhibitor (ARNI) for eligible patients with heart failure with reduced ejection fraction (HFrEF). Using data from the Get With The Guidelines–Heart Failure registry, we evaluated the early impact of this update on temporal trends in ARNI prescription. Methods We analyzed patients with HFrEF who were eligible for ARNI prescription (EF ≤40%, no contraindications) and hospitalized from February 20, 2016, through August 19, 2016—allowing for 13 weeks before and after guideline publication. We quantified trends in ARNI use associated with guidelines publication with an interrupted time-series design using logistic regression and accounting for correlations within hospitals using general estimating equation methods. Results Of 7,200 eligible patient hospitalizations, 51.9% were discharged in the period directly preceding publication of the guidelines, and 48.1% were discharged after. Odds ratios of ARNI prescription at discharge were significantly higher in the postguideline period compared with the preguideline period in adjusted models (adjusted odds ratio 1.29, 95% CI 1.06-1.57, P = .01). However, there was no significant interaction between observed and expected ARNI use after guideline publication (Pinteraction = .14). Results were consistent using a 6-month before and after time frame. Conclusions The model suggested a small increase in ARNI use in HF patients being discharged from the hospital immediately after guideline release. However, the publication of national guidelines recommending ARNI use seemed to have little influence on the adoption of this evidence-based medication in the first 3 to 6 months.

Background Heart failure (HF) with preserved ejection fraction (HFpEF) is more common in women than in men; data characterizing sex differences in the management and outcomes of HFpEF patients presenting to the emergency department (ED) are limited. Methods and Results Using Acute Decompensated Heart Failure National Registry Emergency Module data linked to Medicare claims, we conducted a retrospective analysis of acute HF patients in the ED, identifying HFpEF (ejection fraction [EF] ≥40%) patients and stratifying by sex to compare baseline characteristics, ED therapies, hospital length of stay (LOS), in-hospital mortality, and post-discharge outcomes. Of 4161 HFpEF patients, 2808 (67%) were women, who were more likely to be older and hypertensive, but less likely to be diabetic or smokers (all P 140 mm Hg (62.5% vs 56.4%; P = .0001) and higher EF. There were no sex differences in ED therapies, adjusted 30- and 180-day all-cause mortality, in-hospital mortality, or 30- and 180-day readmissions. After adjustment, women had longer LOS (0.40 days, 95% confidence interval [CI] 0.10–0.70; P = .008). Conclusions Women with HFpEF presenting to the ED were more likely to have elevated systolic blood pressure, but overall ED management strategies were similar to those in men. We observed adjusted differences in hospital LOS, but no differences in 30- and 180-day outcomes.

Background The angiotensin‐receptor/neprilysin inhibitor (ARNI) sacubitril/valsartan reduces hospitalization and mortality for patients with heart failure with reduced ejection fraction. However, adoption of ARNI into clinical practice has been slow. Factors influencing use of ARNI have not been fully elucidated. Using data from the Get With The Guidelines‐Heart Failure registry, Hospital Compare, Dartmouth Atlas, and the American Hospital Association Survey, we sought to identify hospital characteristics associated with patient‐level receipt of an ARNI prescription. Methods and Results We analyzed patients with heart failure with reduced ejection fraction who were eligible for ARNI prescription (ejection fraction≤40%, no contraindications) and hospitalized from October 1, 2015 through December 31, 2016. We used logistic regression to estimate the associations between hospital characteristics and patient ARNI prescription at hospital discharge, accounting for clustering of patients within hospitals using generalized estimating equation methods and adjusting for patient‐level covariates. Of 16 674 eligible hospitalizations from 210 hospitals, 1020 patients (6.1%) were prescribed ARNI at discharge. The median hospital‐level proportion of patients prescribed ARNI was 3.3% (Q1, Q3: 0%, 12.6%). After adjustment for patient‐level covariates, for‐profit hospitals had significantly higher odds of ARNI prescription compared with not‐for‐profit hospitals (odds ratio, 2.53; 95% CI, 1.05–6.10; P=0.04), and hospitals located in the Western United States had lower odds of ARNI prescription compared with those in the Northeast (odds ratio, 0.33; 95% CI, 0.13–0.84; P=0.02). Conclusions Relatively few hospital characteristics were associated with ARNI prescription at hospital discharge, in contrast to what has been observed in early adoption in other disease areas. Additional evaluation of barriers to implementing new evidence into heart failure practice is needed., See Editorial by Bergethon and Wasfy

Background The 2013 American College of Cardiology/American Heart Association Cholesterol Treatment Guideline increased the number of primary prevention patients eligible for statin therapy, yet uptake of these guidelines has been modest. Little is known of how primary care provider ( PCP ) beliefs influence statin prescription. Methods and Results We surveyed 164 PCP s from a community‐based North Carolina network in 2017 about statin therapy. We evaluated statin initiation among the PCP s’ statin‐eligible patients between 2014 and 2015 without a previous prescription. Seventy‐two PCP s (43.9%) completed the survey. The median estimate of the relative risk reduction for high‐intensity statins was 45% (interquartile range, 25%–50%). A minority of providers (27.8%) believed statins caused diabetes mellitus, and only 16.7% reported always/very often discussing this with patients. Most PCPs (97.2%) believed that statins cause myopathy, and 72.3% reported always/very often discussing this with patients. Most (77.7%) reported always/very often using the 10‐year atherosclerotic cardiovascular disease risk calculator, although many reported that in most cases other risk factors or patient preferences influenced prescribing (59.8% and 43.1%, respectively). Of 6172 statin‐eligible patients, 22.3% received a prescription for a moderate‐ or high‐intensity statin at follow‐up. Providers reporting greater reliance on risk factors beyond atherosclerotic cardiovascular disease risk were less likely to prescribe statins. Conclusions Although beliefs and approaches to statin discussions vary among community PCP s, new prescription rates are low and minimally associated with those beliefs. These results highlight the complexity of increasing statin prescriptions for primary prevention and suggest that strategies to facilitate standardized discussions and to address external influences on patient beliefs warrant future study.

Elevated heart rate of ≥70 beats/min despite β-blocker use may represent a new treatment target in patients in sinus rhythm with heart failure with reduced ejection fraction. However, little is known about the proportion of patients with elevated heart rate despite β-blocker therapy.We analyzed data from a large clinical registry to describe discharge heart rate as a function of β-blocker use and dose. We included patients with left ventricular ejection fraction40% who were admitted with acute heart failure in 2003 and 2004; we excluded patients with a history of atrial arrhythmia or with a pacemaker or cardiac resynchronization therapy. We considered the β-blockers carvedilol, metoprolol succinate, bisoprolol, atenolol, and metoprolol tartrate and described discharge dose as a percentage of target dose (ie,25%, 25%-49%, 50%-99%, and ≥100%).Among 10,696 patients, median discharge heart rate was 76 beats/min (interquartile range [IQR] 66-86 beats/min). Of these, 7,826 (73%) were discharged on a β-blocker. For patients not on a β-blocker, median discharge heart rate was 80 beats/min (IQR 70-89 beats/min), compared with 78 beats/min (IQR 69-88 beats/min) on25% of target dose, 75 beats/min (IQR 66-85 beats/min) on 25% to 49% of target dose, 74 beats/min (IQR 66-82 beats/min) on 50% to 99% of target dose, and 72 beats/min (IQR 65% to 80%) on 100% of target dose or greater (P.001). Most patients, 7,647 (71%), had a discharge heart rate of ≥70 beats/min, including 1,460 (63%) of 2,301 patients discharged on 50% of target dose or greater.Despite treatment with β-blockers, a substantial proportion of patients hospitalized with heart failure with reduced ejection fraction have elevated heart rate at discharge.

Importance There are major gaps in use of guideline-directed medical therapy (GDMT) for patients with heart failure (HF). Patient-reported data outlining patient goals and preferences associated with GDMT are not available. Objective To survey patients with chronic HF to better understand their experiences and perceptions of living with HF, including their familiarity and concerns with important GDMT therapies. Design, Setting, and Participants Study participants were recruited from the GfK KnowledgePanel, a probability-sampled online panel representative of the US adult population. English-speaking adults who met the following criteria were eligible if they were (1) previously told by a physician that they had HF; (2) currently taking medications for HF; and (3) had no history of left ventricular assist device or cardiac transplant. Data were collected between October and November 2018. Analysis began in December 2018. Main Outcomes and Measures The survey included 4 primary domains: (1) relative importance of disease-related goals, (2) challenges associated with living with HF, (3) decision-making process associated with HF medication use, and (4) awareness and concerns about available HF medications. Results Of 30 707 KnowledgePanel members who received the initial survey, 15 091 (49.1%) completed the screening questions, 440 were eligible and began the survey, and 429 completed the survey. The median (interquartile range) age was 68 (60-75) years and most were white (320 [74.6%]), male (304 [70.9%]), and had at least a high school education (409 [95.3%]). Most survey responders reported familiarity with β-blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and diuretics. Overall, 107 (24.9%) reported familiarity with angiotensin receptor–neprilysin inhibitors or mineralocorticoid receptor antagonists. Overall, 136 patients (42.5%) reported have safety concerns regarding angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, and 133 (38.5%) regarding β-blockers, 35 (37.9%) regarding mineralocorticoid receptor antagonists, 38 (36.5%) regarding angiotensin receptor–neprilysin inhibitors, and 123 (37.2%) regarding diuretics. Between 27.7% (n = 26) and 38.5% (n = 136) reported concerns regarding the effectiveness of β-blockers, angiotensin receptor–neprilysin inhibitors, mineralocorticoid receptor antagonists, or diuretics, while 41% (n = 132) were concerned with the effectiveness of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers. Conclusions and Relevance In this survey study, many patients were not familiar with GDMT for HF, with familiarity lowest for angiotensin receptor–neprilysin inhibitors and mineralocorticoid receptor antagonists. Among patients not familiar with these therapies, significant proportions questioned their effectiveness and/or safety. Enhanced patient education and shared decision-making support may be effective strategies to improve the uptake of GDMT for HF in US clinical practice.

BackgroundSurveys of patients with cardiovascular disease have suggested that "home-time"-being alive and out of any health care institution-is a prioritized outcome. This novel measure has not been studied among patients with heart failure (HF).ObjectivesThis study sought to characterize home-time following hospitalization for HF and assess its relationship with patient characteristics and traditionally reported clinical outcomes.MethodsUsing GWTG-HF (Get With The Guidelines-Heart Failure) registry data, patients discharged alive from an HF hospitalization between 2011 and 2014 and≥65 years of age were identified. Using Medicare claims, post-discharge home-time over 30-day and 1-year follow-up was calculated for each patient as the number of days alive and spent outside of a hospital, skilled nursing facility (SNF), or rehabilitation facility.ResultsAmong 59,736 patients, 57,992 (97.1%) and 42,153 (70.6%) had complete follow-up for home-time calculation through 30days and 1 year, respectively. The mean home-time was 21.6 ± 11.7days at 30days and 243.9 ± 137.6days at 1 year. Contributions to reduced home-time varied by follow-up period, with days spent in SNF being the largest contributor though 30days and death being the largest contributor through 1 year. Over 1 year, 2,044 (4.8%) patients had no home-time following index hospitalization discharge, whereas 8,194 (19.4%) had 365days of home-time. In regression models, several conditions were associated with substantially reduced home-time, including chronic obstructive pulmonary disease, renal insufficiency, and dementia. Through 1 year, home-time was highly correlated with time-to-event endpoints of death (tau=0.72) and the composite of death or HF readmission (tau=0.59).ConclusionsHome-time, which can be readily calculated from administrative claims data, is substantially reduced for many patients following hospitalization for HF and is highly correlated with traditional time-to-event mortality and hospitalization outcomes. Home-time represents a novel, easily measured, patient-centered endpoint that may reflect effectiveness of interventions in future HF studies.

Background— The accuracy of stroke diagnosis in administrative claims for a contemporary population of Medicare enrollees has not been studied. We assessed the validity of diagnostic coding algorithms for identifying stroke in the Medicare population by linking data from the REasons for Geographic And Racial Differences in Stroke (REGARDS) Study to Medicare claims. Methods and Results— The REGARDS Study enrolled 30 239 participants ≥45 years in the United States between 2003 and 2007. Stroke experts adjudicated suspected strokes, using retrieved medical records. We linked data for participants enrolled in fee-for-service Medicare to claims files from 2003 through 2009. Using adjudicated strokes as the gold standard, we calculated accuracy measures for algorithms to identify incident and recurrent strokes. We linked data for 15 089 participants, among whom 422 participants had adjudicated strokes during follow-up. An algorithm using primary discharge diagnosis codes for acute ischemic or hemorrhagic stroke ( International Classification of Diseases, Ninth Revision, Clinical Modification codes: 430, 431, 433.x1, 434.x1, 436) had a positive predictive value of 92.6% (95% confidence interval, 88.8%–96.4%), a specificity of 99.8% (99.6%–99.9%), and a sensitivity of 59.5% (53.8%–65.1%). An algorithm using only acute ischemic stroke codes (433.x1, 434.x1, 436) had a positive predictive value of 91.1% (95% confidence interval, 86.6%–95.5%), a specificity of 99.8% (99.7%–99.9%), and a sensitivity of 58.6% (52.4%–64.7%). Conclusions— Claims-based algorithms to identify stroke in a contemporary Medicare cohort had high positive predictive value and specificity, supporting their use as outcomes for etiologic and comparative effectiveness studies in similar populations. These inpatient algorithms are unsuitable for estimating stroke incidence because of low sensitivity.

Background: Data demonstrate a positive relationship between socioeconomic status (SES) and cardiovascular health (CVH).Objective: To assess the association between individual- and neighborhood-level SES and CVH among participants of the JHS (Jackson Heart Study), a community-based cohort of African Americans in Jackson, Mississippi.Methods: We included all JHS participants with complete SES and CVH information at the baseline study visit (n = 3,667). We characterized individual- and neighborhood-level SES according to income (primary analysis) and education (secondary analysis), respectively. The outcome of interest for these analyses was a CVH score, based on 7 modifiable behaviors and factors, summed to a total of 0 (worst) to 14 (best) points. We utilized generalized estimating equations to account for the clustering of participants within the same residential areas to estimate the linear association between SES and CVH.Results: The median age of the participants was 55 years, and 64% were women. Nearly one-third of eligible participants had individual incomes

Background— Reducing hospital readmissions for patients with heart failure is a national priority, and quality improvement campaigns are targeting reductions of ≥20%. However, there are limited data on whether such targets have been met. Methods and Results— We analyzed data from the American Heart Association’s Get With The Guidelines-Heart Failure registry linked to Medicare claims between 2009 and 2012 to describe trends and relative reduction of rates of 30-day all-cause readmission among patients with heart failure. A total of 21,264 patients with heart failure were included from 70 US sites from January 2009 to October 2012. Overall hospital-level, risk-adjusted, 30-day all-cause readmission rates declined slightly, from 20.0% (SD, 1.3%) in 2009 to 19.0% (SD, 1.2%) in 2012 ( P =0.001). Only 1 in 70 (1.4%) hospitals achieved the 20% relative reduction in 30-day risk-adjusted readmission rates. A multivariable linear regression model was used to determine hospital-level factors associated with relative improvements in 30-day risk-adjusted readmissions between 2009 and 2012. Teaching hospitals had higher relative readmission rates as compared with their peers, and hospitals that used postdischarge heart failure disease management programs had lower relative readmission rates. Conclusions— Although there has been slight improvement in 30-day all-cause readmission rates during the past 4 years in patients with heart failure, few hospitals have seen large success.

There are limited data describing outcomes associated with an elevated heart rate in patients with heart failure with reduced ejection fraction (HFrEF) in routine clinical practice. We identified patients with HFrEF at Duke University Hospital undergoing echocardiograms and heart rate assessments without paced rhythms or atrial fibrillation. Outcomes (all-cause mortality or hospitalization and medical costs per day alive) were assessed using electronic medical records, hospital cost accounting data, and national death records. Patients were stratified by heart rate (

Purpose: Complex and sometimes controversial information must be conveyed during the consent process for participation in biorepositories, and studies suggest that consent documents in general are growing in length and complexity. As a first step toward creating a simplified biorepository consent form, we gathered data from multiple stakeholders about what information was most important for prospective participants to know when making a decision about taking part in a biorepository. Methods: We recruited 52 research participants, 12 researchers, and 20 institutional review board representatives from Durham and Kannapolis, NC. These subjects were asked to read a model biorepository consent form and highlight sentences they deemed most important. Results: On average, institutional review board representatives identified 72.3% of the sentences as important; researchers selected 53.0%, and participants 40.4% (P = 0.0004). Participants most often selected sentences about the kinds of individual research results that might be offered, privacy risks, and large-scale data sharing. Researchers highlighted sentences about the biorepository's purpose, privacy protections, costs, and participant access to individual results. Institutional review board representatives highlighted sentences about collection of basic personal information, medical record access, and duration of storage. Conclusion: The differing mandates of these three groups can translate into widely divergent opinions about what information is important and appropriate to include a consent form. These differences could frustrate efforts to move simplified forms—for biobanking as well as for other kinds of research—into actual use, despite continued calls for such forms.

Studies of conflicts of interest in clinical research have focused on academic centers, but most clinical research takes place in nonacademic settings.To compare oversight and management of investigators' financial relationships in academic and nonacademic research settings.Survey of officials at 199 sites that contributed participants to commercially sponsored phase 3 clinical trials published in JAMA or the New England Journal of Medicine in 2006 and 2007.Response rates were 66% for academic medical centers, 37% for nonacademic medical centers (inpatient), and 27% for outpatient nonacademic sites. Almost all academic medical centers (97%) and most nonacademic medical centers (87%) followed written conflict-of-interest policies, whereas 44% of outpatient nonacademic sites had written policies (P0.001). Academic and nonacademic medical centers relied mainly on internal institutional review boards (69% and 71%, respectively); outpatient nonacademic sites relied primarily on independent institutional review boards (59%; P0.001).Nonacademic sites have substantially different approaches to the oversight and management of financial relationships in commercially sponsored clinical research than academic medical centers. These differences warrant more attention to how financial relationships are monitored in community research settings.

This study describes the availability and characteristics of databases in Asian-Pacific countries and assesses the feasibility of a distributed network approach in the region.A web-based survey was conducted among investigators using healthcare databases in the Asia-Pacific countries. Potential survey participants were identified through the Asian Pharmacoepidemiology Network.Investigators from a total of 11 databases participated in the survey. Database sources included four nationwide claims databases from Japan, South Korea, and Taiwan; two nationwide electronic health records from Hong Kong and Singapore; a regional electronic health record from western China; two electronic health records from Thailand; and cancer and stroke registries from Taiwan.We identified 11 databases with capabilities for distributed network approaches. Many country-specific coding systems and terminologies have been already converted to international coding systems. The harmonization of health expenditure data is a major obstacle for future investigations attempting to evaluate issues related to medical costs.

In 2009, the Centers for MedicareMedicaid Services (CMS) began publicly reporting 30-day hospital readmission rates for patients discharged with acute myocardial infarction (MI), heart failure (HF), or pneumonia.This study assessed trends of 30-day readmission rates and post-discharge care since the implementation of CMS public reporting.We analyzed Medicare claims data from 2006 to 2012 for patients discharged after a hospitalization for MI, HF, or pneumonia. For each diagnosis, we estimated trends in 30-day all-cause readmissions and post-discharge care (emergency department visits and observation stays) by using hospitalization-level regression models. We modeled adjusted trends before and after the implementation of public reporting. To assess for a change in trend, we tested the difference between the slope before implementation and the slope after implementation.We analyzed 37,829 hospitalizations for MI, 100,189 for HF, and 79,076 for pneumonia from4,100 hospitals. When considering only recent trends (i.e., since 2009), we found improvements in adjusted readmission rates for MI (-2.3%), HF (-1.8%), and pneumonia (-2.0%), but when comparing the trend before public reporting with the trend after reporting, there was no difference for MI (p = 0.72), HF (p = 0.19), or pneumonia (p = 0.21). There were no changes in trends for 30-day post-discharge care for MI or pneumonia; however, the trend decreased for HF emergency department visits from 2.3% to -0.8% (p = 0.007) and for observation stays from 15.1% to 4.1% (p = 0.04).The release of the CMS public reporting of hospital readmission rates was not associated with any measurable change in 30-day readmission trends for MI, HF, or pneumonia, but it was associated with less hospital-based acute care for HF.

Background— Although the informed consent process is supposed to help potential research participants make informed and voluntary decisions about participating in research, little is known about how participants react to language in the informed consent document and whether their reactions are related to their willingness to enroll in clinical trials. We examined the relationship between patients’ reactions to standard informed consent language and their willingness to participate in a hypothetical clinical trial. Methods and Results— We simulated the consent process for a hypothetical cardiology clinical trial with 470 patients in an outpatient cardiovascular medicine clinic at a large academic medical center. We analyzed the spontaneous comments and questions that participants made during the interviews about each section of the informed consent document. Few participants made positive comments. Participants made the most negative comments about the sections on risks, study purpose or protocol, and payment for injury. Having a negative reaction to any section was associated with a lower likelihood of participating in the clinical trial. Using a multivariable model, we found that negative reactions in the patient rights, financial disclosure, and confidentiality sections predicted willingness to participate ( P Conclusions— Recognizing elements of informed consent that elicit questions and concerns from potential research participants may help investigators design clinical research trials and model language in a way that reduces concerns or increases participant understanding, thereby enhancing informed consent for research.

Little is known about the effects of investigators' financial disclosures on potential research participants.We conducted a vignette trial in which 470 participants in a telephone survey were randomly assigned to receive a simulated informed consent document that contained 1 of 2 financial disclosures (per capita payments to the research institution or equity ownership by the investigator) or no disclosure. The main outcome measures were trust in medical research and willingness to participate in a hypothetical clinical trial.Participants in the equity group reported less willingness to participate than participants in the per capita payments group (P = .01) and the no disclosure group (P = .03). Trust in the investigator was highest in the per capita payments group and lowest in the equity group (P.001). Trust among participants who received no disclosure was also greater than trust among participants in the equity group (P = .04) but did not differ significantly from trust among participants in the per capita payments group (P = .15). Participants in the equity group made 3 times as many negative comments as participants in the per capita payments group; and 10 participants in the equity group spontaneously said they would not participate in the hypothetical trial because of the financial interest, compared with only 1 such participant from the other groups.Although investigators' financial disclosures in research do not substantially affect willingness to participate, potential research participants are more troubled by equity interests than by per capita payments.

Background: Consent forms have lengthened over time and become harder for participants to understand. We sought to demonstrate the feasibility of creating a simplified consent form for biobanking that comprises the minimum information necessary to meet ethical and regulatory requirements. We then gathered preliminary data concerning its content from hypothetical biobank participants. Methodology/Principal Findings: We followed basic principles of plain-language writing and incorporated into a 2-page form (not including the signature page) those elements of information required by federal regulations and recommended by best practice guidelines for biobanking. We then recruited diabetes patients from community-based practices and randomized half (n=56) to read the 2-page form, first on paper and then a second time on a tablet computer. Participants were encouraged to use ‘‘More information’’ buttons on the electronic version whenever they had questions or desired further information. These buttons led to a series of ‘‘Frequently Asked Questions’’ (FAQs) that contained additional detailed information. Participants were asked to identify specific sentences in the FAQs they thought would be important if they were considering taking part in a biorepository. On average, participants identified 7 FAQ sentences as important (mean 6.6, SD 14.7, range: 0–71). No one sentence was highlighted by a majority of participants; further, 34 (60.7%) participants did not highlight any FAQ sentences. Conclusions: Our preliminary findings suggest that our 2-page form contains the information that most prospective participants identify as important. Combining simplified forms with supplemental material for those participants who desire more information could help minimize consent form length and complexity, allowing the most substantively material information to be better highlighted and enabling potential participants to read the form and ask questions more effectively.