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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

Background Individuals with chronic kidney disease (CKD), hypertension (HTN), or diabetes mellitus (DM) are at increased risk for cardiovascular disease (CVD). The extent to which psychosocial factors are associated with increased CVD risk within these individuals is unclear. Black individuals experience a high degree of psychosocial stressors due to socioeconomic factors, environment, racism, and discrimination. We examined the association between psychosocial factors and risk of CVD events among Black men and women with CKD and CKD risk factors in the Jackson Heart Study. Methods and Results We identified 1919 participants with prevalent CKD or CKD risk factors at baseline. We used rotated principal component analysis - a form of unsupervised machine learning that may identify constructs not intuitively identified by a person - to describe five groups of psychosocial components (including negative moods, religiosity, discrimination, negative outlooks, and negative coping resources) based on a battery of questionnaires. Multiple imputation by chained equation (MICE) was used to impute missing covariate data. Cox models were used to quantify the association between psychosocial components and incident CVD, defined as a fatal coronary heart disease event, myocardial infarction, cardiac procedure (angiography or revascularization procedure), or stroke. Of the 929 participants in the analysis, 67% were female, 28% were current/former smokers with mean age of 56 years and mean BMI of 33 kg/m2. Over a median follow-up of 8 years, 6% had an incident CVD event. In multivariable models, each standard deviation (SD) increase in the religiosity component was associated with an increased hazard for CVD event (hazard ratio [HR] = 1.52, 95% CI: 1.09–2.13). Conclusions Religiosity was associated with CVD among participants with prevalent CKD or CKD risk factors. Studies to better understand the mechanisms of this relationship are needed.

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.

The revised British Association of Sexual Health and HIV UK guidelines on the management of syphilis were published in 2015 and this audit measures performance against those standards and recommendations. Although not included in the guideline recommendations, an exploratory question on clinics’ HIV testing policy was also included. The audit was conducted over a two-month period in 2017 in genitourinary medicine (GUM) clinics across the UK of cases presenting in 2016. A total of 161 GUM clinics participated, and data were collected for 3017 cases. The standard for adherence to recommended treatment was met (97%, standard: 97%) and almost met for documented pre-treatment syphilis serology (95%, standard: 97%). Even though only 74% of patients had a documented action in relation to informing sexual contacts (standard: 97%), the standard for contacts seen and tested per index case within four weeks was met (0.9, standard: 0.6). Finally, those clinics with a formal policy on HIV testing after a syphilis diagnosis were twice as likely to test after the HIV window period, compared to clinics without a policy; a concurrent HIV diagnosis was made in 75 (3%) patients. More work is required to standardize documented delivery of effective partner notification and a formal policy on HIV testing appears to be effective.

Background Medicare insurance claims may provide an efficient means to ascertain follow-up of older participants in clinical research. We sought to determine the accuracy and completeness of claims- versus site-based follow-up with clinical event committee (+CEC) adjudication of cardiovascular outcomes. Methods We performed a retrospective study using linked Medicare and Duke Database of Clinical Trials data. Medicare claims were linked to clinical data from 7 randomized cardiovascular clinical trials. Of 52,476 trial participants, linking resulted in 5,839 (of 10,497 linkage-eligible) Medicare-linked trial participants with fee-for-service A and B coverage. Death, myocardial infarction (MI), stroke, and revascularization incidences were compared using Medicare inpatient claims only, site-reported events (+CEC) only, or a combination of the 2. Randomized treatment effects were compared as a function of whether claims-based, site-based (+CEC), or a combined system was used for event detection. Results Among the 5,839 study participants, the annual event rates were similar between claims- and site-based (+CEC) follow-up: death (overall rate 5.2% vs 5.2%; adjusted κ 0.99), MI (2.2% vs 2.3%; adjusted κ 0.96), stroke (0.7% vs 0.7%; adjusted κ 0.99), and any revascularization (7.4% vs 7.9%; adjusted κ 0.95). Of events detected by claims yet not reported by CEC, a minority were reported by sites but negatively adjudicated by CEC (39% of MIs and 18% of strokes). Differences in individual case concordance led to higher event rates when claims- and site-based (+CEC) systems were combined. Randomized treatment effects were similar among the 3 approaches for each outcome of interest. Conclusions Claims- versus site-based (+CEC) follow-up identified similar overall cardiovascular event rates despite meaningful differences in the events detected. Randomized treatment effects were similar using the 2 methods, suggesting claims data could be used to support clinical research leveraging routinely collected data. This approach may lead to more effective evidence generation, synthesis, and appraisal of medical products and inform the strategic approaches toward the National Evaluation System for Health Technology.

ImportancePatient-reported health data can facilitate clinical event capture in pragmatic clinical trials. However, few data are available on the fitness for use of patient-reported data in large-scale health research.ObjectiveTo evaluate the concordance of a set of variables reported by patients and available in the electronic health record as part of a pragmatic clinical trial.Design, Setting, and ParticipantsData from ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness), a pragmatic clinical trial, were used in a concordance substudy of a comparative effectiveness research trial. The trial randomized 15 076 patients with existing atherosclerotic cardiovascular disease in a 1:1 ratio to low- or high-dose aspirin from April 2016 through June 30, 2019.Main Outcomes and MeasuresConcordance of data was evaluated from 4 domains (demographic characteristics, encounters, diagnoses, and procedures) present in 2 data sources: patient-reported data captured through an online portal and data from electronic sources (electronic health record data). Overall agreement, sensitivity, specificity, positive predictive value, negative predictive value, and κ statistics with 95% CIs were calculated using patient report as the criterion standard for demographic characteristics and the electronic health record as the criterion standard for clinical outcomes.ResultsOf 15 076 patients with complete information, the median age was 67.6 years (range, 21-99 years), and 68.7% were male. With the use of patient-reported data as the criterion standard, agreement (κ) was high for Black and White race and ethnicity but only moderate for current smoking status. Electronic health record data were highly specific (99.6%) but less sensitive (82.5%) for Hispanic ethnicity. Compared with electronic health record data, patient report of clinical end points had low sensitivity for myocardial infarction (33.0%), stroke (34.2%), and major bleeding (36.6%). Positive predictive value was similarly low for myocardial infarction (40.7%), stroke (38.8%), and major bleeding (21.9%). Coronary revascularization was the most concordant event by data source, with only moderate agreement (κ = 0.54) and positive predictive value. Agreement metrics varied by site for all demographic characteristics and several clinical events.Conclusions and RelevanceIn a concordance substudy of a large, pragmatic comparative effectiveness research trial, sensitivity and chance-corrected agreement of patient-reported data captured through an online portal for cardiovascular events were low to moderate. Findings suggest that additional work is needed to optimize integration of patient-reported health data into pragmatic research studies.Trial RegistrationClinicalTrials.gov Identifier: NCT02697916

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.

BACKGROUND: The appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy. METHODS: Using an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardiovascular disease to a strategy of 81 mg or 325 mg of aspirin per day. The primary effectiveness outcome was a composite of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke, assessed in a time-to-event analysis. The primary safety outcome was hospitalization for major bleeding, also assessed in a time-to-event analysis. RESULTS: A total of 15,076 patients were followed for a median of 26.2 months (interquartile range [IQR], 19.0 to 34.9). Before randomization, 13,537 (96.0% of those with available information on previous aspirin use) were already taking aspirin, and 85.3% of these patients were previously taking 81 mg of daily aspirin. Death, hospitalization for myocardial infarction, or hospitalization for stroke occurred in 590 patients (estimated percentage, 7.28%) in the 81-mg group and 569 patients (estimated percentage, 7.51%) in the 325-mg group (hazard ratio, 1.02; 95% confidence interval [CI], 0.91 to 1.14). Hospitalization for major bleeding occurred in 53 patients (estimated percentage, 0.63%) in the 81-mg group and 44 patients (estimated percentage, 0.60%) in the 325-mg group (hazard ratio, 1.18; 95% CI, 0.79 to 1.77). Patients assigned to 325 mg had a higher incidence of dose switching than those assigned to 81 mg (41.6% vs. 7.1%) and fewer median days of exposure to the assigned dose (434 days [IQR, 139 to 737] vs. 650 days [IQR, 415 to 922]). CONCLUSIONS: In this pragmatic trial involving patients with established cardiovascular disease, there was substantial dose switching to 81 mg of daily aspirin and no significant differences in cardiovascular events or major bleeding between patients assigned to 81 mg and those assigned to 325 mg of aspirin daily. (Funded by the Patient-Centered Outcomes Research Institute; ADAPTABLE ClinicalTrials.gov number, NCT02697916.).

PURPOSE: Chemotherapy-induced peripheral neuropathy (CIPN) is a disabling complication of many chemotherapies. We investigated the feasibility of using health plan claims and administrative data to identify CIPN occurrence by comparing patients who received neurotoxic and non-neurotoxic chemotherapies. METHODS: The sample included over 53,000,000 patients from two regional and one national insurer in the U.S. (>400,000 exposed to chemotherapy). Peripheral neuropathy was identified using a broad definition (Definition 1) and a specific definition (i.e., drug-induced polyneuropathy code) (Definition 2). RESULTS: CIPN incidence as measured by Definition 1 within 6 months of chemotherapy initiation was 18.1% and 6.2% for patients who received neurotoxic and non-neurotoxic chemotherapy, respectively (relative risk neurotoxic vs. non-neurotoxic (RR): 2.93 (95% CI: 2.87-2.98)). For Definition 2, these incidences were 3.6% and 0.1% (RR: 25.2 (95% CI: 22.8-27.8)). The incidences of new analgesic prescriptions for neurotoxic and non-neurotoxic groups were as follows: gabapentin, 7.1%/1.7%; pregabalin, 0.69%/0.31%; and duloxetine, 0.78%/0.76%. The incidence of CIPN as defined by Definitions 1 and 2 was low compared to that of published research studies, but the relative risk of CIPN among patients who received neurotoxic chemotherapies compared to those who received non-neurotoxic chemotherapies was high using Definition 2. CONCLUSIONS: These data suggest that as used currently by clinicians, administrative codes likely underestimate CIPN incidence. Thus, studies using administrative data to estimate CIPN incidence are not currently feasible. However, the drug-induced polyneuropathy code is a specific indicator of CIPN in administrative data and may be useful for investigating predictors or potentially preventive therapies of CIPN.

Some individuals with diabetes fast during Ramadan despite medical concerns for risk of adverse outcomes. The Managing Diabetes During Ramadan Conversation Map is a self-management education group-based intervention for Muslim individuals with type 2 diabetes, specifically addressing diabetes management during Ramadan.The aim of this study was to evaluate the effectiveness of the Managing Diabetes During Ramadan Conversation Map intervention in improving short-term clinical outcomes and reducing healthcare utilization following Ramadan.This was a retrospective rolling cohort study.Participants were Clalit Health Services members with type 2 diabetes who participated in the intervention between 2014 and 2017 across Israel.This study included 1732 participants who enrolled in the intervention over the five-year study period. The cohort was mainly between the ages of 45 and 74 years (83.3%), female (71.9%), of lower socioeconomic status (92.1%), with a diabetes duration of 10 years or more (51.7%), obese (64.0%), and had never smoked (73.8%).The data used in this study came from Clalit Health Services' electronic health records, which are integrated in a central data warehouse. We used a difference-in-differences (self-comparison) design to examine the effect of the intervention on changes in laboratory results and healthcare utilization over a six month baseline and follow-up. Mixed model linear regressions and Poisson regressions were used to estimate continuous and count outcomes, respectively.Post intervention, participants experienced a reduction of 8.61 mg/dL in their glucose levels (p = 0.005) and 0.34% in their HbA1c levels (p 0.001). In a sub-group analysis of participants with HbA1c 7%, larger reductions in glucose (17.02 mg/dL [p 0.001]) and HbA1c (0.63% [p 0.001]) levels were recorded. This sub-group also experienced a reduction of 4.83 mg/dL in LDL level (p = 0.007) and had 0.2 fewer primary care visits (p 0.001).Participation in the Managing Diabetes During Ramadan Conversation Map improved patient glucose and HbA1c levels. A greater benefit was reported in those individuals with HbA1c 7%. These findings hold important global health implications for the millions of individuals with type 2 diabetes for whom Ramadan can pose a challenge in disease control.

AIM To determine the incidence of severe hypoglycaemia and its predictors in community-based patients with type 2 diabetes studied between 2008 and 2013 compared with those in a cohort of patients with type 2 diabetes from the same geographical area assessed a decade earlier. METHODS We studied 1551 participants (mean age 65.7 years, 51.9% men) with type 2 diabetes from the longitudinal observational Fremantle Diabetes Study Phase II (FDS2). Severe hypoglycaemia was ascertained as that requiring ambulance attendance, emergency department services and/or hospitalization. Cox proportional hazards modelling was used to determine predictors of a first episode of severe hypoglycaemia, and negative binomial regression was used to identify predictors of frequency. RESULTS Sixty-three participants (4.1%) experienced 83 episodes, representing an incidence of 1.34/100 participant-years (95% confidence interval [CI] 1.08 to 1.67; vs 1.67/100 participant-years [95% CI 1.31-2.13] in the Fremantle Diabetes Study Phase I [FDS1]; P = 0.18). Those experiencing severe hypoglycaemia experienced one to four episodes in both cohorts. The independent predictors of incident severe hypoglycaemia in the FDS2 were: older age; higher educational attainment; alcohol consumption; current smoking; sulphonylurea/insulin treatment; prior severe hypoglycaemia; renal impairment; and plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP). The same variables except smoking were associated with frequency of severe hypoglycaemia. Most of these risk factors paralleled those in the FDS1, but current smoking and plasma NT-proBNP were novel. CONCLUSIONS The incidence and frequency of severe hypoglycaemia did not change between the Fremantle Diabetes Study phases but novel risk factors, including plasma NT-proBNP, were observed in the FDS2.

INTRODUCTION Transfusion-related acute lung injury (TRALI), an adverse event occurring during or within 6 hours of transfusion, is a leading cause of transfusion-associated fatalities reported to the US Food and Drug Administration. There is limited information on the validity of diagnosis codes for TRALI recorded in inpatient electronic medical records (EMRs). STUDY DESIGNS AND METHODS We conducted a validation study to establish the positive predictive value (PPV) of TRALI International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes recorded within a large hospital system between 2013 and 2015. A physician with critical care expertise confirmed the TRALI diagnosis. As TRALI is likely underdiagnosed, we used the specific code (518.7), and codes for respiratory failure (518.82) in combination with transfusion reaction (999.80, 999.89, E934.7). RESULTS Among almost four million inpatient stays, we identified 208 potential TRALI cases with ICD-9-CM codes and reviewed 195 medical records; 68 (35%) met clinical definitions for TRALI (26 [38%] definitive, 15 [22%] possible, 27 [40%] delayed). Overall, the PPV for all inpatient TRALI diagnoses was 35% (95% confidence interval (CI), 28-42). The PPV for the TRALI-specific code was 44% (95% CI, 35-54). CONCLUSION We observed low PPVs (

Aims To report long-term outcomes of patients treated with stereotactic ablative radiotherapy (SABR) for early stage, peripherally located non-small cell lung cancer. Materials and methods Data were collected retrospectively between September 2009 and May 2019. Electronic medical records were reviewed for baseline characteristics, treatment details and outcomes. All patients were treated according to local protocol based on the national UK SABR Consortium guidelines. Risk-adapted treatment schedules were used depending on the size and the location of the tumour (54 Gy in three fractions, 55 Gy in five fractions, 60 Gy in eight fractions or 50 Gy in 10 fractions). Overall survival outcomes were evaluated using the Kaplan–Meier method. Results In total, 412 patients were included in the analysis. The median age was 76 years (range 48–93 years). Histological confirmation was obtained in 233 cases (56.6%). The median overall survival for all patients was 42.3 months (95% confidence interval 37.3–47.3 months), with 3- and 5-year overall survival of 52.8% and 37.3%, respectively. For biopsy-proven patients (56.6%), 3- and 5-year overall survival was 57.3% and 40.1%, respectively. With respect to overall survival, univariate and multivariate analysis revealed no significant difference in survival by technique (volume-modulated arc therapy versus conformal; three-dimensional computed tomography versus four-dimensional computed tomography), tumour location, smoking status at first contact, pre-treatment tumour stage or pre-treatment standardised uptake value. Survival was poorer for patients who received the 50 Gy in 10 fractions schedule. Treatment was very well tolerated with very low rates of grade 3–4 toxicity (1%). Conclusions SABR for peripherally located, medically inoperable non-small cell lung cancer can be safely and effectively implemented in a non-academic institution with appropriate equipment and training. Overall survival outcomes and toxicity rates are comparable with internationally published studies. Patients treated with 50 Gy in 10 fractions had a poorer survival outcome.

Objectives: The aim of the study was to describe a UK‐wide process to assess adherence to guidelines for the routine investigation and monitoring of HIV‐positive adults aged ≥ 50 years and provide clinical services with individual feedback to support improvement in quality of care. / Methods: The British HIV Association (BHIVA) invited HIV clinical care sites to provide retrospective data from case notes of up to 40 adults aged ≥ 50 years with HIV‐1 infection attending the clinic for care during 2017 and/or 2018, using a structured dynamic online questionnaire. / Results: A total of 4959 questionnaires from 141 clinical services were returned. Regarding the key targets specified in the BHIVA monitoring guidelines, 97% of patients on antiretroviral therapy (ART) had had their viral load measured in the last 9 months, or 15 months if on a protease inhibitor, and 94% had had all medications recorded in the last 15 months. Only 67% of patients on ART without cardiovascular disease (CVD) had had a 10‐year CVD risk calculated in the last 3 years. It was reported that 80% and 92% had had their smoking status documented in the last 2 years and blood pressure checked in the last 15 months, respectively. HIV services had communicated with the general practitioners of 90% of consenting individuals, but consulted electronic primary care records for only 10%. / Conclusions: Nationally, targets were met for viral load and blood pressure monitoring but not for CVD risk assessment, smoking status documentation and recording of comedication. There was variable performance in relation to other outcomes; adherence and laboratory measurements were carried out more regularly than lifestyle and wellbeing assessments.

BACKGROUND Linking clinical registries to administrative claims data enables researchers to capitalize on the specific strengths of each data source with respect to the depth, breadth, and completeness of information. The objectives of this study were to link a health-system-based orthopaedic surgery registry to U.S. Medicare claims data without the use of unique identifiers and to assess the representativeness of the linked records. METHODS The registry included clinical data for patients ≥65 years of age who underwent elective, inpatient total ankle arthroplasty (TAA) in a single health system during the period of 2007 through 2012. Registry participants were identified within the Medicare data by linking registry procedures to TAA procedures within the claims data using a combination of procedure date, patient date of birth, and patient sex. We assessed the representativeness of the linked records by comparing them to both unlinked registry records and unlinked Medicare records for TAA procedures. Additionally, we described the availability of postsurgical data for linked records. RESULTS Of 360 TAA registry participants ≥65 years of age, 280 (77.8%) were matched to a Medicare record; 250 (89.3%) of those 280 participants were matched on the basis of a linking rule that required an exact match for procedure date, date of birth, and sex. The 280 linked records comprised 5.5% of all Medicare TAA procedures among beneficiaries ≥65 years of age enrolled in the fee-for-service Medicare program (n = 5,070). Compared with linked records, unlinked records were more likely to be for patients 65 to 69 years old, but the 2 groups were similar in terms of sex, body mass index, and availability of clinical measurements. Of the linked records, 214 (76.4%) had ≥3 years of postoperative follow-up claims data. CONCLUSIONS Linkage without unique patient identifiers between an orthopaedic registry and Medicare claims data is feasible, allows for assessment of representativeness, and creates a unique resource of longitudinal data for research.

Background Non-adherence to medications is common and leads to suboptimal outcomes. Non-adherence can be intentional (e.g., deciding to skip dosages) or unintentional (e.g., forgetting), yet few studies have distinguished these reasons. An improved understanding of the reasons for non-adherence could inform the development of effective interventions. Methods and Results We analyzed data from African Americans in the Jackson Heart Study who were prescribed medications for one or more chronic conditions. Participants were grouped by patient-reported adherence with non-adherence categorized as being intentional, unintentional or both. We used modified Poisson regression models to examine the factors associated with types of non-adherence. Of 2933 participants taking medication, 2138 (72.9%) reported non-adherence with 754 (35.3%) reporting only unintentional non-adherence, 263 (12.3%) only intentional non-adherence, and 1121 (52.4%) both. Factors independently associated with intentional non-adherence included female sex and depressive symptoms while factors associated with unintentional non-adherence included younger age and separated relationship status. Unintentional and intentional non-adherence was more common among participants taking anti-arrhythmic and anti-asthmatic medications, respectively. Higher levels of global perceived stress was associated with both types of non-adherence. The adjusted models for intentional and unintentional non-adherence had c-statistics of 0.65 and 0.66, respectively, indicating modest discrimination. Conclusion Specific patient factors and individual medication classes were associated with distinct patterns of intentional and unintentional non-adherence, yet the overall modest discrimination of the models suggests contributions from other unmeasured factors. These findings provide a construct for understanding reasons for non-adherence and provide rationale to assess whether personalized interventions can improve adherence.

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: Prior studies have reported higher in-hospital survival with prompt defibrillation and epinephrine treatment in patients with in-hospital cardiac arrest (IHCA). Whether this survival benefit persists after discharge is unknown. Methods: We linked data from a national IHCA registry with Medicare files and identified 36 961 patients ≥65 years of age with an IHCA at 517 hospitals between 2000 and 2011. Patients with IHCA caused by pulseless ventricular tachycardia or ventricular fibrillation were stratified by prompt (≤2 minutes) versus delayed (>2 minutes) defibrillation, whereas patients with IHCA caused by asystole or pulseless electric activity were stratified by prompt (≤5 minutes) versus delayed (>5 minutes) epinephrine treatment. The association between prompt treatment and long-term survival for each rhythm type was assessed with multivariable hierarchical modified Poisson regression models. Results: Of 8119 patients with an IHCA caused by ventricular tachycardia or ventricular fibrillation, the rate of 1-year survival was higher in those treated with prompt defibrillation than with delayed defibrillation (25.7% [1466 of 5714] versus 15.5% [373 of 2405]; adjusted relative risk [RR], 1.49; 95% confidence interval [CI] 1.32–1.69; P P P P =0.02), but this survival benefit was no longer present at 3 years (3.5% versus 2.9%; adjusted RR, 1.17; 95% CI, 0.95–1.45; P =0.15) and at 5 years (2.3% versus 1.9%; adjusted RR, 1.18; 95% CI, 0.88–1.58; P =0.27). Conclusions: Prompt defibrillation for IHCA caused by ventricular tachycardia or ventricular fibrillation was associated with higher rates of long-term survival throughout 5 years of follow-up, whereas prompt epinephrine treatment for asystole/pulseless electric activity was associated with greater survival at 1 year but not at 3 or 5 years. By quantifying the greater survival associated with timely defibrillation and epinephrine administration, these findings provide important insights into the durability of survival benefits for 2 process-of-care measures in current resuscitation guidelines.

Heart failure with preserved ejection fraction may be associated with chronotropic incompetence, but little is known about the incidence and prevalence of permanent pacemaker use in this population or factors associated with its use.We analyzed patients with heart failure with preserved ejection fraction (ie, left ventricular ejection fraction greater than 40%) from the ADHERE registry (2001-2006) linked with Medicare claims. We described the use of both prevalent and incident permanent pacemakers in heart failure with preserved ejection fraction and determined factors associated with pacemaker use with logistic regression models.Among 13,881 patients with heart failure with preserved ejection fraction, 3136 (22.6%) had a permanent pacemaker, and of these patients, 636 had a permanent pacemaker implanted during hospitalization. Permanent pacemaker use was more common among older patients (81 vs 79 years; P.001), men (38% vs 34%; P.001), patients with atrial fibrillation (58% vs 36%; P.001), and patients with wider QRS duration (140 ms vs 94 ms; P.001). Rates of digoxin, aldosterone antagonist, and loop diuretic use were slightly higher in patients with a permanent pacemaker compared with patients with no permanent pacemaker. Factors associated with both prevalent and incident pacemaker use included age, fast or slow heart rate, atrial fibrillation, and lower body mass index.Use of permanent pacemakers is relatively common among patients with heart failure with preserved ejection fraction.

BACKGROUND The Jackson Heart Study (JHS) assesses cardiovascular disease risk factors among African Americans in Jackson, Mississippi. Whether characteristics of JHS participants differ from those of a broader African American population are unknown. METHODS In a retrospective observational analysis, we compared characteristics and outcomes of JHS participants 65 years old and older and enrolled in Medicare (n = 1,105) to regional (n = 57,489) and national (n = 95,494) cohorts of African American Medicare beneficiaries. We weighted the regional and national cohorts to match the age and sex distributions of the JHS-Medicare cohort for pairwise baseline comparisons. Outcomes of interest included mortality and Medicare costs. We used Cox proportional hazards models to test associations between cohorts and outcomes. RESULTS The JHS-Medicare cohort was younger, included more women, and had fewer beneficiaries with dual Medicare-Medicaid eligibility, compared with regional and national Medicare cohorts. The cohort also had lower risks of stroke, lung disease, heart failure, diabetes, and renal disease. Mean Medicare costs were lower ($5,066 [SD = $11,932]) than in the regional ($7,419 [SD = $17,574]) and national ($8,013 [SD = $19,378]) cohorts. The regional and national cohorts had higher mortality (adjusted hazard ratios = 1.52; 95% confidence interval [CI] = 1.31, 1.76; and 1.49; 95% CI = 1.29, 1.73, respectively). Subgroup analysis for dual Medicare-Medicaid eligibility attenuated mortality differences. CONCLUSION JHS-Medicare participants had fewer comorbid conditions, better survival, and lower Medicare costs compared with regional and national cohorts. Observed differences may reflect healthy volunteer bias and higher socioeconomic status.See video abstract at, http://links.lww.com/EDE/B235.

MitraClip is an approved therapy for mitral regurgitation (MR); however, health care resource utilization pre- and post-MitraClip remains understudied.Patients with functional and degenerative MR at high surgical risk in the EVEREST II High-Risk Registry and REALISM Continued-Access Study were linked to Medicare data. Pre- and post-MitraClip all-cause death, stroke, myocardial infarction, heart failure (HF), and bleeding hospitalizations were identified. Inpatient costs, adjusted to 2010 US dollars, were calculated, and event rate ratios and cost ratios were estimated with multivariable modeling.Among 403 linked patients, the mean age was 80 years, 60% were male, mean baseline left ventricular ejection fraction was 49.6%, 83.3% were New York Heart Association class III/IV, 78.2% were MR grade 3+/4+, and 63.3% had functional MR. All-cause hospitalization decreased from 1,854 to 1,435/1,000 person-years (P.001). HF hospitalization decreased following MitraClip (749 vs 332/1000 person-years, P.001), but bleeding increased (199 vs 298/1000 person-years, P.001). Changes in stroke and myocardial infarction were not statistically significant. Overall mean Medicare costs per patient were similar pre- and post-MitraClip, although there was a significant decrease in mean costs among those that survived a full year after MitraClip ($18,131 [SD $25,130] vs $11,679 [SD $22,486], P=.02).MitraClip was associated with a reduced rate of all-cause and HF hospitalizations and an increased rate of bleeding hospitalizations. One-year Medicare costs were reduced in those who survived a full year after the MitraClip procedure. Payors and providers seeking to reduce HF hospitalizations and associated Medicare costs may consider MitraClip among appropriate patients likely to survive 1 year.

Medicare beneficiaries with multiple chronic conditions are typically seen by multiple providers, particularly specialists. Clinically appropriate referrals to multiple specialists may compromise the continuity of care for multiple chronic condition beneficiaries and create care plans that patients may find challenging to reconcile, which may impact patient outcomes.The objective was to examine whether glycemic control or lipid control was associated with the number of prescribers of cardiometabolic medications.A retrospective cross-sectional cohort analysis of 51,879 elderly Medicare fee-for-service beneficiaries with diabetes and 129,762 beneficiaries with dyslipidemia living in 10 east coast states. Glycemic control was defined as having an HbA1c7.5. Lipid control was defined as an low-density lipoprotein100 for beneficiaries with heart disease or diabetes or an low-density lipoprotein130 for all other beneficiaries. We examined the association between the number of prescribers of cardiometabolic medications and disease or lipid control in 2011 through logistic regression, controlling for age, sex, race, Medicaid enrollment, 17 chronic conditions and state-fixed effects.Among beneficiaries with diabetes, 76% with one prescriber had well-controlled diabetes in 2011, which decreased to 65% for beneficiaries with 5+ prescribers. In adjusted analyses, Medicare beneficiaries with 3 or more prescribers were less likely to have glycemic control than beneficiaries with a single prescriber. Among those with dyslipidemia, nearly all (91%-92%) beneficiaries had lipid control. After adjustment for demographics and comorbidity burden, beneficiaries with 3 prescribers were less likely to have lipid control than beneficiaries with a single prescriber.Multiple prescribers were associated with worse disease control, possibly because patients with more severe diabetes or dyslipidemia have multiple prescribers or because care fragmentation is associated with worse disease control.

Background Significant analysis errors can be caused by nonvalidated data quality of electronic health records data. To determine surgical data fitness, a framework of foundational and study-specific data analyses was adapted and assessed using conformance, completeness, and plausibility analyses. Study Design Electronic health records-derived data from a cohort of 241,695 patients undergoing 412,182 procedures from October 1, 2014 to August 31, 2018 at 3 hospital sites was evaluated. Data quality analyses tested CPT codes, medication administrations, vital signs, provider notes, labs, orders, diagnosis codes, medication lists, and encounters. Results Foundational checks showed that all encounters had procedures within the inclusion period, all admission dates occurred before discharge dates, and race was missing for 1% of patients. All procedures had associated CPT codes, 69% had recorded blood pressure, pulse, temperature, respiration rate, and oxygen saturation. After curation, all medication matched RxNorm medication naming standards, 84% of procedures had current outpatient medication lists, and 15% of procedures had missing procedure notes. Study-specific checks temporally validated CPT codes, intraoperative medication doses were in conventional units, and of the 13,500 patients who received blood pressure medication intraoperatively, 93% had a systolic blood pressure >140 mmHg. All procedure notes were completed within less than 30 days of the procedure and 93% of patients after total knee arthroplasty had postoperative physical therapy notes. All patients with postoperative troponin-T lab values ≥0.10 ng/mL had more than 1 ECG with relevant diagnoses. Postoperative opioid prescription decreased by 8.8% and nonopioid use increased by 8.8%. Conclusions High levels of conformance, completeness, and clinical plausability demonstrate higher quality of real-world data fitness and low levels demonstrate less-fit-for-use data.

AIM To evaluate the association between the image quality of cancer staging whole-body magnetic resonance imaging (WB-MRI) and patient demographics, distress, and perceived scan burden. MATERIALS AND METHODS A sample of patients recruited prospectively to multicentre trials comparing WB-MRI with standard scans for staging lung and colorectal cancer were invited to complete two questionnaires. The baseline questionnaire, administered at recruitment, collated data on demographics, distress and co-morbidity. The follow-up questionnaire, completed after staging investigations, measured perceived WB-MRI scan burden (scored 1 low to 7 high). WB-MRI anatomical coverage, and technical quality was graded by a radiographic technician and grading combined to categorise the scan as “optimal”, “sub-optimal” or “degraded”. A radiologist categorised 30 scans to test interobserver agreement. Data were analysed using the chi-square, Fisher's exact, t-tests, and multinomial regression. RESULTS One hundred and fourteen patients were included in the study (53 lung, 61 colorectal; average age 65.3 years, SD=11.8; 66 men [57.9%]). Overall, 45.6% (n=52), scans were classified as “optimal” quality, 39.5% (n=45) “sub-optimal”, and 14.9% (n=17) as “degraded”. In adjusted analyses, greater deprivation level and higher patient-reported scan burden were both associated with a higher likelihood of having a sub-optimal versus an optimal scan (odds ratio [OR]: 4.465, 95% confidence interval [CI]: 1.454 to 13.709, p=0.009; OR: 1.987, CI: 1.153 to 3.425, p=0.013, respectively). None of the variables predicted the likelihood of having a degraded scan. CONCLUSIONS Deprivation and patients' perceived experience of the WB-MRI are related to image quality. Tailored protocols and individualised patient management before and during WB-MRI may improve image quality.

The purpose of this study was to evaluate the association of physical activity (PA) level and longitudinal PA trajectory with a composite heart failure hospitalization and mortality endpoint over a 5-year follow-up period following implantation.Low device measured PA early after implantation of an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) is associated with poor outcomes.We linked daily PA data from the Boston Scientific ALTITUDE dataset of patients with ICD or CRT-D implantation to Medicare claims data. We used a joint model to investigate the association of the composite endpoint with 1) the time-varying point estimate of PA and 2) the time-varying trajectory/slope of PA during follow-up.Among 20,927 patients with median activity level 85 min/day, 14.1% and 49.6% experienced the composite endpoint at 1 and 5 years. Adjusted joint model results showed that there was a 1.13 (95% confidence interval: 1.12 to 1.13)-fold increase in the hazard of the composite endpoint for 75 min of daily PA relative to 85 min of PA; and a within-patient 10-min decrease in average daily PA over an 8-week period from 85 to 75 min was associated with a hazard ratio of 4.02 (95% confidence interval: 3.82 to 4.22) for the composite endpoint.Patients with large decreases in PA have significantly higher risk of experiencing heart failure hospitalization or death. PA data from implantable devices may identify patients before clinical decompensation.

BackgroundData from randomized controlled trials and observational studies on older adults who take statins for primary prevention of atherosclerotic cardiovascular disease are limited. To determine the incidence of statin use in older adults with and without cardiovascular disease (CVD) and/or diabetes (DM), we conducted a descriptive observational study.MethodsThe cohort consisted of health plan members in the NIH Collaboratory Distributed Research Network aged >75 years who had continuous drug and medical benefits for ≥183 days during the study period, January 1, 2008- March 31, 2018. We defined DM and CVD using diagnosis codes, and identified statins using dispensing data. Statin use was considered incident if a member had no evidence of statin exposure in the claims during the previous 183 days, and the use was considered long-term if statins were supplied for ≥180 days. Incidence rates were reported among members with and without CVD and/or diabetes, and stratified by year, sex, and age group.ResultsAmong 757,569 eligible members, 109,306 older adults initiated statins and 54,624 became long-term users. Health plan members with CVD had the highest incidence of statin use (143.9 initiators per 1,000 member-years for CVD & DM; 114.5 initiators per 1,000 member-years for CVD & No DM). Among health plan members without CVD, those with DM had rates of statin use that were over two times higher than members without DM (76.1 versus 34.5 initiators per 1,000 member-years, respectively). Statin initiation remained steady throughout 2008-2016, was slightly higher in males, and declined with increasing age.ConclusionIncidence of statin use varied by CVD and DM comorbidity, and was lowest among those without CVD. These results highlight the potential clinical equipoise to conduct large pragmatic clinical trials to generate evidence that could be used to inform future blood cholesterol guidelines.

Objectives This study sought to describe clinical outcomes among patients with atrial fibrillation (AF) and contraindications to oral anticoagulation (OAC). Background Treatment with OAC prevents stroke and death in patients with AF, but may be contraindicated among patients at high bleeding risk. Methods This was an observational, longitudinal analysis of a nationally representative 5% Medicare sample of patients with chronic AF and CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65–74 years, sex category) score ≥2. They were stratified by both the presence of high bleeding risk contraindications to OAC and by OAC use. We assessed 3-year ischemic and bleeding outcomes using multivariable Cox proportional hazards models adjusted for relevant patient characteristics. Results Among 26,684 AF patients not treated with OAC, 8,283 (31%) had a high bleeding risk contraindication, primarily a blood dyscrasia (75%) or history of gastrointestinal bleeding (40%). Without OAC, patients with contraindications had worse ischemic and bleeding outcomes at 3 years compared with those without contraindications. We also identified 12,454 patients with OAC contraindications who received OAC. Compared with patients not receiving OAC, use of OAC was associated with reduced mortality (adjusted hazard ratio [HR]: 0.79; 95% confidence interval [CI]: 0.76 to 0.83), stroke (adjusted HR: 0.90; 95% CI: 0.83 to 0.99), and all-cause hospitalization (adjusted HR: 0.93; 95% CI: 0.90 to 0.96) but increased risk of intracranial hemorrhage (adjusted HR: 1.42; 95% CI: 1.17 to 1.72). Conclusions High bleeding risk contraindications to OAC are common among older patients with AF, and these patients have higher mortality compared with untreated patients without OAC contraindications. The use of OAC in these patients is associated with lower rates of all-cause stroke, hospitalization, and death but higher risk of intracranial hemorrhage.

Background Emerging data suggest that neck circumference (NC) is associated with cardiometabolic risk factors. Limited research is available regarding the association between NC and cardiovascular outcomes in African Americans. Methods Using data from the Jackson Heart Study, we included participants with recorded NC measurements at baseline (2000-2004). Baseline characteristics for the included population were summarized by tertiles of NC. We then calculated age- and sex-adjusted cumulative incidence of clinical cardiovascular outcomes and performed Cox proportional-hazards with stepwise models. Results Overall, 5,290 participants were categorized into tertiles of baseline NC defined as ≤37 cm (n = 2179), 38-40 cm (n = 1552), and >40 cm (n = 1559). After adjusting for age and sex, increasing NC was associated with increased risk of heart failure (HF) hospitalization (cumulative incidence = 13.4% [99% CI, 10.7-16.7] in the largest NC tertile vs 6.5% [99% CI, 4.7-8.8] in the smallest NC tertile), but not mortality, stroke, myocardial infarction, or coronary heart disease (all P ≥ .1). Following full risk adjustment, there was a nominal increase in the risk of HF hospitalization with increasing NC, but this was not statistically significant (hazard ratio per 1-cm increase, 1.04 [99% CI, 0.99-1.10], P = .06). Conclusions In this large cohort of African American individuals, a larger NC was associated with increased risk for HF hospitalization following adjustment for age and sex, but this risk was not statistically significant after adjusting for other clinical variables. Although NC is not independently associated with increased risk for cardiovascular events, it may offer prognostic information particularly related to HF hospitalization.

Congestion is associated with adverse outcomes in heart failure (HF) patients. We characterized congestion in patients hospitalized for HF and examined the association between congestion severity at admission and postdischarge outcomes. Using the OPTIMIZE-HF registry linked to Medicare claims, we analyzed patients ≥65 years old hospitalized for HF from 2003 to 2004. Congestion severity was measured using a 15-point scale that scores dyspnea, orthopnea, fatigue, jugular venous pressure, rales, and edema. Patient characteristics and outcomes were described by congestion strata. Proportional hazards models were fit to examine associations between congestion and 1-year outcomes. Congestion scores for the 24,724 patients ranged from 0 to 14, with a median of 5 (Q1, Q3: 3, 7). At baseline, patients with the highest scores (≥7) had the highest rates of recent HF hospitalizations, EF ≤40%, and co-morbidities, including arrhythmias, diabetes mellitus, and renal insufficiency. Adjusting for patient characteristics, a 3-point congestion score increase was positively associated with mortality (hazard ratio [HR] 1.06, 95% confidence interval [CI] 1.03, 1.09), all-cause rehospitalization (HR 1.02, 95% CI 1.00, 1.04), and HF rehospitalization (HR 1.09, 95% CI 1.06, 1.12), but not emergency department visits (HR 0.99, 95% CI 0.97, 1.01). In conclusion, for patients hospitalized with HF, congestion was associated with rehospitalization and mortality.

OBJECTIVES The aim of this national audit was to assess adherence of services providing HIV care in the UK to national standards and guidelines regarding psychological support and the assessment of alcohol and recreational drug use (including chemsex drugs) in people living with HIV (PLWH). METHODS Participating sites completed a survey of their services' care pathways relating to psychological support and substance use. They performed a case-note review of up to 40 adult PLWH per service, reviewing sociodemographic and clinical information and assessment of psychological wellbeing, drug use and alcohol use. The surveys and case notes were assessed against relevant British HIV Association (BHIVA) guidelines and standards. RESULTS The survey was completed by 112 services. Of these, 73%, 82% and 73% had formal annual processes for assessing the psychological wellbeing, alcohol use and drug use, respectively, of PLWH. Case-note data were provided for 4486 PLWH from 119 sites. Audited rates of assessment of PLWH were 66.0% for psychological wellbeing, 68.0% for alcohol use, 58.4% for recreational drug use and 16.8% for chemsex drug use. Variation between clinical services was wide, with ranges from

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.

AIMS: To describe global patterns of insulin treatment and to assess the impact of patient, provider, health system and economic influences on treatment decisions for patients with insulin-treated type 2 diabetes (T2D). METHODS: This prospective cohort study of insulin-treated patients with T2D was conducted across 18 countries categorized as high, upper-middle or lower-middle income regions. Information collected from patients included knowledge of diabetes, experiences and interactions with their healthcare provider. Physician information included specialty, practice size, availability of diabetes support services, volume of diabetes patients treated and time spent per patient. Physicians determined an individualized haemoglobin A1c (HbA1c) target for each patient by the start of the study. Changes in T2D therapies and HbA1c were recorded for 2 years. RESULTS: Complete treatment data were available for 2528 patients. Median age was 61 years and median duration of diabetes was 11.4 years. Changes to treatment regimen occurred in 90.0% of patients, but changes were less common in countries with a higher economic status (P

To summarize characteristics of Medicare beneficiaries with type 2 diabetes and to describe changing trends in care and outcomes.We conducted a retrospective cohort study of a nationally representative 5% sample of fee-for-service Medicare beneficiaries 65 years and older with prevalent type 2 diabetes, between January 1, 2002, and December 31, 2011. The main outcome measures were diabetes-related screening tests, mortality, hospital admissions, dialysis, and lower extremity amputation.The average age of Medicare beneficiaries with diabetes was 76.5 years, 56% were women, and 83% were white. Screening practices in beneficiaries with diabetes improved from 2002 to 2011, with rising rates of foot exams, renal screening, hemoglobin A1c tests, and lipid profile tests. The prevalence of nephropathy and neuropathy increased. Although inpatient admissions declined from 2002 to 2011, diabetes-related emergency department visits increased. Amputation and end-stage renal disease remained static, while 1-year mortality declined over the study period.In this medically complex group of patients with high comorbidity, we observed improvements in screening practices and room for further improvement. Although the mortality rate decreased, other outcomes did not improve consistently. Health care resource has changed over time, with decreased hospital admissions and increased emergency department visits.CCW = Chronic Conditions Data Warehouse ESRD = end-stage renal disease HbA1c = hemoglobin A1c HEDIS = Healthcare Effectiveness Data and Information Set ICD-9-CM = International Classification of Diseases, Ninth Revision, Clinical Modification.

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.

Aim To investigate the characteristics of participants in the Diabetes Conversation Map™ (Map™) program who had higher vs. lower compliance to the program, to determine if program tailoring and monitoring is needed among these groups. Methods This was a retrospective cohort study of 8990 patients enrolled in the Map™ program (low compliance [attending 0–1 sessions, n = 2759] and high compliance [attending ≥2 sessions, n = 6231]). Socio-demographic, clinical, health behaviors, and healthcare utilization characteristics were extracted. Multivariable stepwise logistic regression was used as the analysis strategy. Results Those who were of higher socio-economic status (OR = 1.567, 95%CI:1.317–1.865), who lived in urban area (OR = 1.501, 95%CI:1.254–1.798), with greater frequency of primary care visits (OR = 1.012, 95%CI:1.002–1.021), with medium (OR = 1.176, 95%CI:1.013–1.365) or high oral medication adherence (OR = 1.198, 95%CI:1.059–1.356), and with a greater frequency of blood glucose tests (OR = 1.102, 95%CI:1.033–1.175) had greater odds of being in the high compliance group. Conversely, those aged 35–44 (OR = 0.538, 95%CI:0.402–0.721) and 45–54 years (OR = 0.763, 95%CI:0.622–0.937), with longer Type 2 diabetes duration (OR = 0.980, 95%CI:0.967–0.993), with higher blood glucose levels (OR = 0.999, 95%CI:0.998–1.000), and current (OR = 0.659, 95%CI:0.569–0.762) or former smokers (OR = 0.831, 95%CI:0.737–0.938) had reduced odds for being in the higher compliance group. Conclusions Instructors in advance can target sub-groups to increase their attendance rates, and consequently improve their outcomes.

To determine whether therapeutic intensification in type 2 diabetes influences health status and quality of life (QoL).We studied 930 participants in the longitudinal observational Fremantle Diabetes Study Phase II (mean age 65.3 years, 53.8% males, median diabetes duration 8.0 years) with valid data from baseline assessment and two biennial reviews (4 years of follow-up) between 2008 and 2015. The main outcome measures were the Short Form-12 version 2 physical and mental health composite scores (PCS, MCS) and the average weighted impact (AWI) score from the Audit of Diabetes Dependent QoL.There were reductions in PCS at Year 4 compared with baseline and Year 2 in patients on stable diet-based management (n = 160), oral glucose-lowering medication (OGLM; n = 387), and insulin with/without OGLM (n = 168; P 0.05), but no statistically significant temporal changes in MCS/AWI. Insulin-treated patients had the lowest PCS, MCS and AWI compared to the other two subgroups at each time-point (P ≤ 0.012). In participants initiating OGLM (n = 84) or insulin (n = 85), there were no differences in PCS, MCS or AWI at the biennial assessments either side of these therapeutic changes (P ≥ 0.08).These real-life data show that treatment intensification, including insulin initiation, does not impact adversely on patient well-being in community-based type 2 diabetes. Since insulin use at entry was associated with longer diabetes duration, worse glycaemic control, and a greater risk of chronic complications, the burden of disease rather than treatment modality appears the primary determinant of health status and QoL.

Conflicting data exist regarding the associations of early repolarization (ER) with electrocardiogram (ECG) and clinical outcomes in blacks. We examined the association of ER defined by J point elevation (JPE) and all-cause mortality, and heart failure (HF) hospitalization in blacks in the Jackson Heart Study (JHS) cohort. We included JHS participants with ECGs from the baseline visit coding JPE and excluded participants with paced rhythms or QRS duration ≥120 ms. We compared the cumulative incidence of 10-year all-cause mortality and 8-year HF hospitalization by presence of JPE ≥0.1 mV in any ECG lead at baseline using Kaplan-Meier estimates and multivariable Cox models. Of the 4,978 participants, 1,410 (28%) had JPE at baseline: anterior leads 97.8%, lateral leads 8.3%, and inferior leads 2.9%. Compared with participants without JPE, those with JPE were younger, more likely to be male and current smokers, and less likely to have hypertension. Over a median follow-up of 8 years, there were no significant differences in the cumulative incidence or multivariable-adjusted hazards of all-cause mortality or HF hospitalization in participants with and without JPE in any lead (adjusted hazard ratio 0.97, 95% confidence interval 0.89 to 1.52, and adjusted hazard ratio 1.18, 95% confidence interval 0.9 to 1.54, respectively). Of the 2,523 participants who completed Exam 3 without JPE at baseline, 246 (10%) developed JPE over follow-up. In conclusion, JPE on ECG was not associated with long-term mortality or HF hospitalization in a large prospective black community cohort, suggesting that ER may represent a benign ECG finding in blacks.

Background Prior studies have documented racial and ethnic disparities in hospitalization among patients with heart failure (HF). However, racial/ethnic differences in trajectories of hospitalization following the diagnosis of HF have not been well characterized. This study examined racial/ethnic differences in individual‐level trajectories of hospitalization in older adults with diagnosed HF. Methods and Results Data from a nationally representative prospective cohort of US men and women aged 45 years and older were used to examine the number of hospitalizations reported every 24 months. Participants who were non‐Hispanic white, non‐Hispanic black, and Hispanic with a reported diagnosis of HF (n=3011) were followed from 1998 to 2014. Results showed a quadratic change in the number of reported hospitalizations following HF diagnosis, with an average of 2.36 (95% confidence interval [CI], 2.19–2.53; P P P P =0.031]) followed by a sizeable increase in hospitalizations at later stages of disease (Hispanic×time 2 =0.06; 95% CI, 0.00–0.12 [ P =0.047]). In women, hospitalizations were consistently high following their diagnosis and black women had significantly more hospitalizations throughout follow‐up than white women (black=0.28; 95% CI, 0.00–0.55 [ P =0.048]). Racial/ethnic disparities varied by geography and the differences remained significant after adjusting for multiple sociodemographic, psychosocial, behavioral, and physiological factors. Conclusions There were significant racial/ethnic differences in trajectories of hospitalization following the diagnosis of HF in US men and women. Racial/ethnic disparities varied by place of residence and the differences persisted after adjustment for multiple risk factors. The findings have important implications that may be crucial to planning the immediate and long‐term delivery of care in patients with HF to reduce potentially preventable hospitalizations.

To investigate the impact associated with mild hypoglycemia among patients with type 2 diabetes (T2DM) in the United States and to identify risk factors among different subpopulations.We performed a literature search to gather available data allowing estimation of rates of mild hypoglycemia. Because risk factors are interdependent, risk factors included in the model were based on those reported within multivariate analyses or judged to be biologically plausible by the medical community. Based on literature search results, we built a mathematical model predicting the rates of mild hypoglycemia in individual patients as a function of the patient's antidiabetic medications, hemoglobin A1c levels, duration of diabetes, kidney function, and body mass index.We estimated an overall average rate of mild hypoglycemia among US patients with T2DM of 2.2 ± 0.8 events per person per year. Patients taking oral antidiabetic medications only had an average rate of 1.9 ± 0.8 events per person per year. The average rate for all patients taking insulin, including those combining it with other antidiabetic medications, was 4.9 ± 2.0 events per person per year. Mild hypoglycemia rates increased with age, with 80-year-old patients experiencing 1.5 times the risk of 40-year-old patients. Based on published values for direct and indirect medical costs for mild hypoglycemia events, we determined that the economic impact in the US of mild hypoglycemic events is approximately $900 million per year, roughly equal to that of severe hypoglycemic events. One of the key limitations to our model is that it applies to the US population under standard medical care and not to clinical trials and does not include certain known risk factors such as rigorous exercise.Understanding the benefit versus risk of glycemic control and hypoglycemia is fundamental to the successful management of patients with T2DM. Our validated hypoglycemia model is an important step in addressing this issue and may be helpful to researchers, clinicians, and payers to determine the patients who are at the highest risk for hypoglycemia, whether a patient is experiencing events at 'higher-than-expected' rates, and the corresponding economic burden.

The American Diabetes Association consensus statement on the treatment of type 2 diabetes mellitus (T2DM) in older patients highlights the need for treatment pattern and effectiveness data from real-world settings and populations. This retrospective cohort study assessed the relative frequency of use of four commonly prescribed antihyperglycemia treatments for T2DM and quantified their effectiveness up to 2 years post-initiation.Within a large, U.S.-based, electronic health record database, we investigated usage of insulin, sulfonylureas, glucagon-like peptide-1(GLP-1) receptor agonists, and dipeptidyl peptidase-4 (DPP-4) inhibitors in patients with T2DM, focusing on those ≥65 years old, although younger patients were included for comparative purposes.Inclusion criteria were met by 77,440 patients. Mean baseline glycosylated hemoglobin (HbA1c) levels for patients ≥65 years old varied among treatments: insulin (7.7% [61 mmol/mol]; n=3,311), sulfonylureas (7.0% [53 mmol/mol]; n=5,706), GLP-1 receptor agonists (7.1% [54 mmol/mol]; n=260), and DPP-4 inhibitors (7.1% [54 mmol/mol]; n=1,096). Older patients demonstrated good glycemic control at therapy initiation and were prescribed glucose-lowering agents at lower HbA1c values compared with younger patients. A large proportion of older patients were prescribed sulfonylureas (56%) and insulin (34%) compared with GLP-1 receptor agonists (3.4%) and DPP-4 inhibitors (12%), despite the associated risk of hypoglycemia.Patients initiating insulin and sulfonylureas demonstrated more sustained glycemic control compared with GLP-1 receptor agonists and DPP-4 inhibitors. A majority of older patients with T2DM was initiated on sulfonylureas and insulin at relatively low levels of HbA1c, a practice not entirely consistent with the recommendations of published guidelines.

Background. Sudden cardiac death is the leading cause of death among end-stage kidney disease patients (ESKD) on dialysis, but the benefit of primary prevention implantable cardioverter defibrillators (ICDs) in this population is uncertain. We conducted this investigation to compare the mortality of dialysis patients receiving a primary prevention ICD with matched controls. Methods. We used data from the National Cardiovascular Data Registry’s ICD Registry to select dialysis patients who received a primary prevention ICD, and the Get with the Guidelines-Heart Failure Registry to select a comparator cohort. We matched ICD recipients and no-ICD patients using propensity score techniques to reduce confounding, and overall survival was compared between groups. Results. We identified 108 dialysis patients receiving primary prevention ICDs and 195 comparable dialysis patients without ICDs. One year (3-year) mortality was 42.2% (68.8%) in the ICD registry cohort compared with 38.1% (75.7%) in the control cohort. There was no significant survival advantage associated with ICD [hazard ratio (HR) 0.87, 95% confidence interval (CI) 0.66–1.13, log-rank P = 0.29]. After propensity matching, our analysis included 86 ICD patients and 86 matched controls. Comparing the propensity-matched cohorts, 1 year (3 years) mortality was 43.4% (74.0%) in the ICD cohort and 39.7% (76.6%) in the control cohort; there was no significant difference in mortality outcome between groups (HR = 0.94, 95% CI: 0.67– 1.31, log-rank P = 0.71). Conclusions. We did not observe a significant association between primary prevention ICDs and reduced mortality among ESKD patients receiving dialysis. Consideration of the potential risks and benefits of ICD implantation in these patients should be undertaken while awaiting the results of definitive clinical trials.

The objective of this study was to apply quantile regression (QR) methodology to a population from a large representative health insurance plan with known skewed healthcare utilization attributes, co-morbidities, and costs in order to identify predictors of increased healthcare costs. Further, this study provides comparison of the results to those obtained using ordinary least squares (OLS) regression methodology.Members diagnosed with Type 2 Diabetes and with 24 months of continuous enrollment were included. Baseline patient demographic, clinical, consumer/behavioural, and cost characteristics were quantified. Quantile regression was used to model the relationship between the baseline characteristics and total healthcare costs during the follow-up 12 month period.The sample included 83,705 patients (mean age = 70.6 years, 48% male) residing primarily in the southern US (78.1%); 81.2% of subjects were on oral-only anti-diabetic therapy. Co-morbid conditions included nephropathy (43.5%), peripheral artery disease (26.4%), and retinopathy (18.0%). Variables with the strongest relationship with costs during the follow-up period included outpatient visits, ER visits, inpatient visits, and Diabetes Complications Severity Index score during the baseline period. In the top cost quantiles, each additional glycohemoglobin (HbA1c) test was associated with cost savings ($1400 in the 98th percentile). Stage 4 and Stage 5 chronic kidney disease were associated with an incremental cost increase of $33,131 and $106,975 relative to Stage 1 or no CKD in the 98th percentile ($US).These results demonstrate that QR provides additional insight compared to traditional OLS regression modeling, and may be more useful for informing resource allocation to patients most likely to benefit from interventions. This study highlights that the impact of clinical and demographic characteristics on the economic burden of the disease vary across the continuum of healthcare costs. Understanding factors that drive costs on an individual patient level provide important insights that will help in ameliorating the clinical, humanistic, and economic burden of diabetes.

Background— Although an in-hospital cardiac arrest is common, little is known about readmission patterns and an inpatient resource use among survivors of an in-hospital cardiac arrest. Methods and Results— Within a large national registry, we examined long-term inpatient use among 6972 adults aged ≥65 years who survived an in-hospital cardiac arrest. We examined 30-day and 1-year readmission rates and inpatient costs, overall and by patient demographics, hospital disposition (discharge destination), and neurological status at discharge. The mean age was 75.8±7.0 years, 56% were men, and 12% were black. There were a total of 2005 readmissions during the first 30 days (cumulative incidence rate, 35 readmissions/100 patients; 95% confidence interval, 33–37) and 8751 readmissions at 1 year (cumulative incidence rate, 185 readmissions/100 patients; 95% confidence interval, 177–190). Overall, mean inpatient costs were $7741±$2323 at 30 days and $18 629±$9411 at 1 year. Thirty-day inpatient costs were higher in patients of younger age (≥85 years, $6052 [reference]; 75–84 years, $7444 [adjusted cost ratio, 1.23; 1.06–1.42; 65–74 years, $8291 [adjusted cost ratio, 1.37; 1.19–1.59; both P P Conclusions— Survivors of an in-hospital cardiac arrest have frequent readmissions and high follow-up inpatient costs. Readmissions and inpatient costs were higher in certain subgroups, including patients of younger age and black race.

BACKGROUND New-onset atrial fibrillation (AF) is associated with adverse outcomes during a sepsis hospitalization; however, long-term outcomes following hospitalization with sepsis-associated new-onset AF are unclear. METHODS We used a Medicare 5% sample to identify patients who survived hospitalization with sepsis between 1999 and 2010. AF status was defined as no AF, prior AF, or new-onset AF based on AF claims during and prior to a sepsis hospitalization. We used competing risk models to determine 5-year risks of AF occurrence, heart failure, ischemic stroke, and mortality after the sepsis hospitalization, according to AF status during the sepsis admission. RESULTS We identified 138,722 sepsis survivors, of whom 95,536 (69%) had no AF during sepsis, 33,646 (24%) had prior AF, and 9,540 (7%) had new-onset AF during sepsis. AF occurrence following sepsis hospitalization was more common among patients with new-onset AF during sepsis (54.9%) than in patients with no AF during sepsis (15.5%). Compared with patients with no AF during sepsis, those with new-onset AF during sepsis had greater 5-year risks of hospitalization for heart failure (11.2% vs 8.2%; multivariable-adjusted hazard ratio [HR], 1.25; 95% CI, 1.16-1.34), ischemic stroke (5.3% vs 4.7%; HR, 1.22; 95% CI, 1.10-1.36), and death (74.8% vs 72.1%; HR, 1.04; 95% CI,1.01-1.07). CONCLUSIONS Most sepsis survivors with new-onset AF during sepsis have AF occur after discharge from the sepsis hospitalization and have increased long-term risks of heart failure, ischemic stroke, and death. Our findings may have implications for posthospitalization surveillance of patients with new-onset AF during a sepsis hospitalization.

Pharmacotherapy and supportive care for diabetes in Australia are improving, with potential beneficial effects on therapeutic procrastination.To determine whether glycaemic thresholds for therapeutic intensification in type 2 diabetes changed over the 15 years between phases of the community-based Fremantle Diabetes Study (FDS).We studied 531 Phase 1 participants (mean age 62.4 years, 54.2% males, median diabetes duration 3.0 years) with valid data from baseline assessment and five subsequent annual reviews between 1993 and 2001 and 930 Phase 2 participants (mean age 65.3 years, 53.8% males, median diabetes duration 8.0 years) with valid data from baseline and two subsequent biennial reviews between 2008 and 2015. The main outcome measure was HbANinety-seven participants in Phase 1 and 84 in Phase 2 progressed from diet-based management to oral hypoglycaemic agents (OHA) and 45 and 85 participants, respectively, progressed from diet/OHA to insulin. The median HbAHbA

Background Prior studies have demonstrated a link between the metabolic syndrome and increased risk of cardiovascular mortality. Whether the metabolic syndrome is associated with sudden cardiac death is uncertain. Methods and Results We characterized the relationship between sudden cardiac death and metabolic syndrome status among participants of the ARIC (Atherosclerosis Risk in Communities) Study (1987–2012) free of prevalent coronary heart disease or heart failure. Among 13 168 participants, 357 (2.7%) sudden cardiac deaths occurred during a median follow‐up of 23.6 years. Participants with the metabolic syndrome (n=4444) had a higher cumulative incidence of sudden cardiac death than those without it (n=8724) (4.1% versus 2.3%, P P P =0.10) or race (interaction P =0.62) and was mediated by the metabolic syndrome criteria components. The risk of sudden cardiac death varied according to the number of metabolic syndrome components (hazard ratio 1.31 per additional component of the metabolic syndrome, 95% confidence interval, 1.19–1.44, P Conclusions We observed that the metabolic syndrome was associated with a significantly increased risk of sudden cardiac death irrespective of sex or race. The risk of sudden cardiac death was proportional to the number of metabolic syndrome components.

Background Studies have shown that access to routine medical care is associated with the prevention, diagnosis, and treatment of chronic diseases. However, studies have not examined whether patient-reported difficulties in access to care are associated with rehospitalization in patients with cardiovascular disease. Methods Electronic medical records and a standardized survey were used to examine cardiovascular patients admitted to a large medical center from January 1, 2015 through January 10, 2017 (n = 520). All-cause readmission within 30 days of discharge was the primary outcome for analysis. Logistic regression models were used to examine the association between access to care and 30-day readmission while adjusting for patient demographics, socioeconomic status, healthcare utilization, and health status. Results Nearly 1-in-6 patients (15.7%) reported difficulty in accessing routine medical care; and those who were younger, male, non-white, uninsured, with heart failure, and had low social support were significantly more likely to report difficulty. Patients who reported difficulty in accessing care had significantly higher rates of 30-day readmission than patients who did not report difficulty (33.3% vs. 17.9%; P = .001); and the risks remained largely unchanged after accounting for nearly two dozen covariates (unadjusted odds ratio [OR] = 2.29; 95% CI, 1.46-3.60 vs. adjusted OR = 2.17; 95% CI, 1.29-3.66). Risks for readmission were especially high for patients who reported issues with transportation (OR = 3.24; 95% CI, 1.28-8.16) and scheduling appointments (OR = 3.56; 95% CI, 1.43-8.84), but not for other reasons (OR = 1.47; 95% CI, 0.61-3.54). Conclusions Cardiovascular patients who reported difficulty in accessing routine care had substantial risks of readmission within 30 days after discharge. These findings have important implications for identifying high-risk patients and developing interventions to improve access to routine medical care.