Showing papers by "Harlan M. Krumholz published in 2018"

Presentation, Clinical Profile, and Prognosis of Young Patients With Myocardial Infarction With Nonobstructive Coronary Arteries (MINOCA): Results From the VIRGO Study.

Abstract: Background We compared the clinical characteristics and outcomes of young patients with myocardial infarction with nonobstructive coronary arteries (MINOCA) versus obstructive disease (myocardial i...

Sex Differences in the Presentation and Perception of Symptoms Among Young Patients With Myocardial Infarction: Evidence from the VIRGO Study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients).

Abstract: Background: Some studies report that women are less likely to present with chest pain for acute myocardial infarction (AMI). Information on symptom presentation, perception of symptoms, and care-seeking behaviors is limited for young patients with AMI. Methods: We interviewed 2009 women and 976 men aged 18 to 55 years hospitalized for AMI at 103 US hospitals participating in the VIRGO study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients). Structured patient interviews during the index AMI hospitalization were used to collect information on symptom presentation, perception of symptoms, and care-seeking behaviors. We compared patient characteristics and presentation information by sex. Multivariable hierarchical logistic regression was used to evaluate the association between sex and symptom presentation. Results: The majority of women (87.0%) and men (89.5%) presented with chest pain (defined as pain, pressure, tightness, or discomfort). Women were more likely to present with ≥3 associated symptoms than men (eg, epigastric symptoms, palpitations, and pain or discomfort in the jaw, neck, arms, or between the shoulder blades; 61.9% for women versus 54.8% for men, P P P =0.029). Approximately 29.5% of women and 22.1% of men sought medical care for similar symptoms before their hospitalization ( P P Conclusions: The presentation of AMI symptoms was similar for young women and men, with chest pain as the predominant symptom for both sexes. Women presented with a greater number of additional non–chest pain symptoms regardless of the presence of chest pain, and both women and their healthcare providers were less likely to attribute their prodromal symptoms to heart disease in comparison with men.

Rationale, Design and Methodology of the Computerized Registry of Patients with Venous Thromboembolism (RIETE).

Abstract: Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a preventable cause of in-hospital death, and one of the most prevalent vascular diseases. There is a lack of knowledge with regards to contemporary presentation, management and outcomes of patients with VTE. Many clinically important subgroups (including the elderly, those with recent bleeding and pregnant patients) have been under-represented in clinical trials. Furthermore, design of clinical trials is challenging in some scenarios, such as in those with hemodynamically unstable PE. RIETE (Registro Informatizado Enfermedad TromboEmbolica) is a large prospective multinational ongoing registry, designed to address these unmet needs using representative data from multiple centres. Initiated in Spain in 2001, RIETE currently includes 179 centres in 24 countries and has enrolled more than 72,000 patients. RIETE has helped characterize the pattern of presentation and outcomes of VTE, including the aforementioned understudied subgroups. RIETE has recently expanded to collect long-term outcome data, and has broadened its inclusion criteria to enrol other forms of venous thrombosis (such as cerebral vein thrombosis and splanchnic vein thrombosis). The RIETE platform is also being used to conduct pragmatic comparative effectiveness studies, including randomized trials. Future steps would focus on collaboration with additional centres across the world, and efforts to ensure the quality and expansion of the registry. In conclusion, RIETE is a large ongoing registry of patients with VTE and other thrombotic conditions. Its results could be helpful for improving our understanding of the epidemiology, patterns of care and outcomes of patients with thrombotic disease.

Comparison of Prevalence, Awareness, Treatment, and Control of Cardiovascular Risk Factors in China and the United States.

Abstract: Background The reasons for China9s high stroke prevalence are not well understood. The cardiovascular risk factor profiles of China and the United States have not been directly compared in nationally representative population samples. Methods and Results Using data from the CHARLS (China Health and Retirement Longitudinal Study) and the NHANES (US National Health and Nutrition Examination Survey), we compared cardiovascular risk factors from 2011 to 2012 among people aged 45 to 75 years between the 2 countries (China, 12 654 people; United States, 2607 people): blood pressure, cholesterol, body mass index, waist circumference, fasting plasma glucose, hemoglobin A1c, and high‐sensitivity C‐reactive protein. Compared with the United States, China had a lower prevalence of hypertension but a higher mean blood pressure and a higher proportion of patients with severe hypertension (≥160/100 mm Hg) (10.5% versus 4.5%). China had substantially lower rates of hypertension treatment (46.8% versus 77.9%) and control (20.3% versus 54.7%). Dyslipidemia was less common in China, but lipid levels were not significantly different because dyslipidemia awareness and control rates in China were 3‐ and 7‐fold lower than US rates, respectively. High‐sensitivity C‐reactive protein, body mass index, and waist circumference were significantly lower in China than in the United States. Clustering of hypertension with other cardiovascular risk factors was more common in China. Conclusions Hypertension is more common in the United States, but blood pressure levels are higher in China, which may be responsible for China9s high stroke prevalence. The low rates of awareness, treatment, and control of hypertension provide an exceptional opportunity for China to reduce risk in its population.

Association of the Hospital Readmissions Reduction Program With Mortality During and After Hospitalization for Acute Myocardial Infarction, Heart Failure, and Pneumonia.

Abstract: Importance The US Hospital Readmissions Reduction Program (HRRP) was associated with reduced readmissions among Medicare beneficiaries hospitalized for acute myocardial infarction (AMI), heart failure (HF), and pneumonia. It is important to assess whether there has been a signal for concomitant harm with an increase in mortality. Objective To evaluate whether the announcement or the implementation of HRRP was associated with an increase in either in-hospital or 30-day postdischarge mortality following hospitalization for AMI, HF, or pneumonia. Design, Setting, and Participants In this cohort study, using Medicare data, all hospitalizations for AMI, HF, and pneumonia were identified among fee-for-service Medicare beneficiaries aged 65 years and older from January 1, 2006, to December 31, 2014. These were assessed for changes in trends for risk-adjusted rates of in-hospital and 30-day postdischarge mortality after announcement and implementation of the HRRP using an interrupted time series framework. Analyses were done in November 2017 and December 2017. Exposures Announcement of the HRRP in March 2010, and implementation of its penalties in October 2012. Main Outcomes and Measures Monthly risk-adjusted rates of in-hospital and 30-day postdischarge mortality. Results The sample included 1.7 million AMI, 4 million HF, and 3.5 million pneumonia hospitalizations. Between 2006 and 2014, in-hospital mortality decreased for the 3 conditions (AMI, from 10.4% to 9.7%; HF, from 4.3% to 3.5%; pneumonia, from 5.3% to 4.0%) while 30-day postdischarge mortality decreased from 7.4% to 7.0% for AMI (Pfor trend .05 for all). In contrast, there were significant negative deflections in slopes for readmission rates at HRRP announcement for all conditions. Conclusions and Relevance Among Medicare beneficiaries, there was no evidence for an increase in in-hospital or postdischarge mortality associated with HRRP announcement or implementation—a period with substantial reductions in readmissions. The improvement in readmission was therefore not associated with any increase in in-hospital or 30-day postdischarge mortality.

Association of Body Mass Index With Blood Pressure Among 1.7 Million Chinese Adults.

Abstract: Importance Body mass index (BMI) is positively associated with blood pressure (BP); this association has critical implications for countries like China, where hypertension is highly prevalent and obesity is increasing. A greater understanding of the association between BMI and BP is required to determine its effect and develop strategies to mitigate it. Objective To assess the heterogeneity in the association between BMI and BP across a wide variety of subgroups of the Chinese population. Design, Setting, and Participants In this cross-sectional study, data were collected at 1 time point from 1.7 million adults (aged 35-80 years) from 141 primary health care sites (53 urban districts and 88 rural counties) from all 31 provinces in mainland China who were enrolled in the China PEACE (Patient-Centered Evaluative Assessment of Cardiac Events) Million Persons Project, conducted between September 15, 2014, and June 20, 2017. A comprehensive subgroup analysis was performed by defining more than 22 000 subgroups of individuals based on covariates, and within each subgroup, linearly regressing BMI to BP. Main Outcomes and Measures Systolic BP was measured twice with the participant in a seated position, using an electronic BP monitor. Results The study included 1 727 411 participants (1 027 711 women and 699 700 men; mean [SD] age, 55.7 [9.8] years). Among the study sample, the mean (SD) BMI was 24.7 (3.5), the mean (SD) systolic BP was 136.5 (20.4) mm Hg, and the mean (SD) diastolic BP was 81.1 (11.2) mm Hg. The increase of BP per unit BMI ranged from 0.8 to 1.7 mm Hg/(kg/m2) for 95% of the subgroups not taking antihypertensive medication. The association between BMI and BP was substantially weaker in subgroups of patients taking antihypertensive medication compared with those who were untreated. In untreated subgroups, 95% of the coefficients varied by less than 1 mm Hg/(kg/m2). Conclusions and Relevance The association between BMI and BP is positive across tens of thousands of individuals in population subgroups, and, if causal, given its magnitude, would have significant implications for public health.

Enhancing the prediction of acute kidney injury risk after percutaneous coronary intervention using machine learning techniques: A retrospective cohort study.

Abstract: Background The current acute kidney injury (AKI) risk prediction model for patients undergoing percutaneous coronary intervention (PCI) from the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) employed regression techniques. This study aimed to evaluate whether models using machine learning techniques could significantly improve AKI risk prediction after PCI. Methods and findings We used the same cohort and candidate variables used to develop the current NCDR CathPCI Registry AKI model, including 947,091 patients who underwent PCI procedures between June 1, 2009, and June 30, 2011. The mean age of these patients was 64.8 years, and 32.8% were women, with a total of 69,826 (7.4%) AKI events. We replicated the current AKI model as the baseline model and compared it with a series of new models. Temporal validation was performed using data from 970,869 patients undergoing PCIs between July 1, 2016, and March 31, 2017, with a mean age of 65.7 years; 31.9% were women, and 72,954 (7.5%) had AKI events. Each model was derived by implementing one of two strategies for preprocessing candidate variables (preselecting and transforming candidate variables or using all candidate variables in their original forms), one of three variable-selection methods (stepwise backward selection, lasso regularization, or permutation-based selection), and one of two methods to model the relationship between variables and outcome (logistic regression or gradient descent boosting). The cohort was divided into different training (70%) and test (30%) sets using 100 different random splits, and the performance of the models was evaluated internally in the test sets. The best model, according to the internal evaluation, was derived by using all available candidate variables in their original form, permutation-based variable selection, and gradient descent boosting. Compared with the baseline model that uses 11 variables, the best model used 13 variables and achieved a significantly better area under the receiver operating characteristic curve (AUC) of 0.752 (95% confidence interval [CI] 0.749–0.754) versus 0.711 (95% CI 0.708–0.714), a significantly better Brier score of 0.0617 (95% CI 0.0615–0.0618) versus 0.0636 (95% CI 0.0634–0.0638), and a better calibration slope of observed versus predicted rate of 1.008 (95% CI 0.988–1.028) versus 1.036 (95% CI 1.015–1.056). The best model also had a significantly wider predictive range (25.3% versus 21.6%, p < 0.001) and was more accurate in stratifying AKI risk for patients. Evaluated on a more contemporary CathPCI cohort (July 1, 2015–March 31, 2017), the best model consistently achieved significantly better performance than the baseline model in AUC (0.785 versus 0.753), Brier score (0.0610 versus 0.0627), calibration slope (1.003 versus 1.062), and predictive range (29.4% versus 26.2%). The current study does not address implementation for risk calculation at the point of care, and potential challenges include the availability and accessibility of the predictors. Conclusions Machine learning techniques and data-driven approaches resulted in improved prediction of AKI risk after PCI. The results support the potential of these techniques for improving risk prediction models and identification of patients who may benefit from risk-mitigation strategies.

Analysis of predicted loss-of-function variants in UK Biobank identifies variants protective for disease

Abstract: Less than 3% of protein-coding genetic variants are predicted to result in loss of protein function through the introduction of a stop codon, frameshift, or the disruption of an essential splice site; however, such predicted loss-of-function (pLOF) variants provide insight into effector transcript and direction of biological effect. In >400,000 UK Biobank participants, we conduct association analyses of 3759 pLOF variants with six metabolic traits, six cardiometabolic diseases, and twelve additional diseases. We identified 18 new low-frequency or rare (allele frequency < 5%) pLOF variant-phenotype associations. pLOF variants in the gene GPR151 protect against obesity and type 2 diabetes, in the gene IL33 against asthma and allergic disease, and in the gene IFIH1 against hypothyroidism. In the gene PDE3B, pLOF variants associate with elevated height, improved body fat distribution and protection from coronary artery disease. Our findings prioritize genes for which pharmacologic mimics of pLOF variants may lower risk for disease.

Association of Out-of-Pocket Annual Health Expenditures With Financial Hardship in Low-Income Adults With Atherosclerotic Cardiovascular Disease in the United States

Abstract: Importance Health insurance is effective in preventing financial hardship from unexpected major health care events. However, it is also essential to assess whether vulnerable patients, particularly those from low-income families, are adequately protected from longitudinal health care costs for common chronic conditions such as atherosclerotic cardiovascular disease (ASCVD). Objective To examine the annual burden of total out-of-pocket health expenses among low-income families that included a member with ASCVD. Design, Setting, and Participants In this cross-sectional study of the Medical Expenditure Panel Survey from January 2006 through December 2015, all families with 1 or more members with ASCVD were identified. Families were classified as low income if they had an income under 200% of the federal poverty limit. Analyses began December 2017. Main Outcomes and Measures Total annual inflation-adjusted out-of-pocket expenses, inclusive of insurance premiums, for all patients with ASCVD. We compared these expenses against annual family incomes. Out-of-pocket expenses of more than 20% and more than 40% of family income defined high and catastrophic financial burden, respectively. Results We identified 22 521 adults with ASCVD, represented in 20 600 families in the Medical Expenditure Panel Survey. They correspond to an annual estimated 23 million or 9.9% of US adults with a mean (SE) age of 65 (0.2) years and included 10.9 million women (47.1%). They were represented in 21 million or 15% of US families. Of these, 8.2 million families (39%) were low income. The mean annual family income was $57 143 (95% CI, $55 377-$58 909), and the mean out-of-pocket expense was $4415 (95% CI, $3735-$3976). While financial burden from health expenses decreased throughout the study, even in 2014 and 2015, low-income families had 3-fold higher odds than mid/high–income families of high financial burden (21.4% vs 7.6%; OR, 3.31; 95% CI, 2.55-4.31) and 9-fold higher odds of catastrophic financial burden (9.8% vs 1.2%; OR, 9.35; 95% CI, 5.39-16.20), representing nearly 2 million low-income families nationally. Further, even among the insured, 1.6 million low-income families (21.8%) experienced high financial burden and 721 000 low-income families (9.8%) experienced catastrophic out-of-pocket health care expenses in 2014 and 2015. Conclusions and Relevance One in 4 low-income families with a member with ASCVD, including those with insurance coverage, experience a high financial burden, and 1 in 10 experience a catastrophic financial burden due to cumulative out-of-pocket health care expenses. To alleviate economic disparities, policy interventions must extend focus to improving not only access, but also quality of coverage, particularly for low-income families.

Racial Disparities in Patient Characteristics and Survival After Acute Myocardial Infarction

Abstract: Importance Black patients experience worse outcomes than white patients following acute myocardial infarction (AMI). Objective To examine the degree to which nonrace characteristics explain observed survival differences between white patients and black patients following AMI. Design, Setting, and Participants This cohort study used the extensive socioeconomic and clinical characteristics from patients recovering from an AMI that were prospectively collected at 31 hospitals across the contiguous United States between 2003 and 2008 for the Prospective Registry Evaluating Myocardial Infarction: Events and Recovery registry and the Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients’ Health Status registry. Survival was assessed using data from the National Death Index. Data were analyzed from December 2016 to July 2018. Main Outcomes and Measures Patient characteristics were categorized into 8 domains, and the degree to which each domain discriminated self-identified black patients from white patients was determined by calculating propensity scores associated with black race for each domain as well as cumulatively across all domains. The final propensity score was associated with 1- and 5-year mortality rates. Results Among 6402 patients (mean [SD] age, 60 [13] years; 2127 [33.2%] female; 1648 [25.7%] black individuals), the 5-year mortality rate following AMI was 28.9% (476 of 1648) for black patients and 18.0% (856 of 4754) for white patients (hazard ratio, 1.72; 95% CI, 1.54-1.92;P Conclusions and Relevance Characteristics of black patients and white patients differed significantly at the time of admission for AMI. Those characteristics were associated with an approximately 3-fold difference in 5-year mortality rate following AMI and mediated most of the observed mortality rate difference between the races.

Overview and experience of the YODA Project with clinical trial data sharing after 5 years.

Abstract: The Yale University Open Data Access (YODA) Project has facilitated access to clinical trial data since 2013. The purpose of this article is to provide an overview of the Project, describe key decisions that were made when establishing data sharing policies, and suggest how our experience and the experiences of our first two data generator partners, Medtronic, Inc. and Johnson & Johnson, can be used to enhance other ongoing or future initiatives.

Risk Factors Associated With Major Cardiovascular Events 1 Year After Acute Myocardial Infarction.

Abstract: Importance Patients who survive acute myocardial infarction (AMI) have a high risk of subsequent major cardiovascular events. Efforts to identify risk factors for recurrence have primarily focused on the period immediately following AMI admission. Objectives To identify risk factors and develop and evaluate a risk model that predicts 1-year cardiovascular events after AMI. Design, Setting, and Participants Prospective cohort study. Patients with AMI (n = 4227), aged 18 years or older, discharged alive from 53 acute-care hospitals across China from January 1, 2013, to July 17, 2014. Patients were randomly divided into samples: training (50% [2113 patients]), test (25% [1057 patients]), and validation (25% [1057 patients]). Risk factors were identified by a Cox model with Markov chain Monte Carlo simulation and further evaluated by latent class analysis. Analyses were conducted from May 1, 2017, to January 21, 2018. Main Outcomes and Measures Major cardiovascular events, including recurrent AMI, stroke, heart failure, and death, within 1 year after discharge for the index AMI hospitalization. Results The mean (SD) age of the cohort was 60.8 (11.8) years and 994 of 4227 patients (23.5%) were female. Common comorbidities included hypertension (2358 patients [55.8%]), coronary heart disease (1798 patients [42.5%]), and dyslipidemia (1290 patients [30.5%]). One-year event rates were 8.1% (95% CI, 6.91%-9.24%), 9.0% (95% CI, 7.22%-10.70%), and 6.4% (95% CI, 4.89%-7.85%) for the training, test, and validation samples, respectively. Nineteen risk factors comprising 15 unique variables (age, education, prior AMI, prior ventricular tachycardia or fibrillation, hypertension, angina, prearrival medical assistance, >4 hours from onset of symptoms to admission, ejection fraction, renal dysfunction, heart rate, systolic blood pressure, white blood cell count, blood glucose, and in-hospital complications) were identified. In the training, test, and validation samples, respectively, the risk model had C statistics of 0.79 (95% CI, 0.75-0.83), 0.73 (95% CI, 0.68-0.78), and 0.77 (95% CI, 0.70-0.83) and a predictive range of 1.2% to 33.9%, 1.2% to 37.9%, and 1.3% to 34.3%. The C statistic was 0.69 (95% CI, 0.65-0.74) for the latent class model in the training data. The risk model stratified 11.3%, 81.0%, and 7.7% of patients to high-, average-, and low-risk groups, with respective probabilities of 0.32, 0.06, and 0.01 for 1-year events. Conclusions and Relevance Nineteen risk factors were identified, and a model was developed and evaluated to predict risk of 1-year cardiovascular events after AMI. This may aid clinicians in identifying high-risk patients who would benefit most from intensive follow-up and aggressive risk factor reduction.

Sex and Race Differences in the Utilization and Outcomes of Coronary Artery Bypass Grafting Among Medicare Beneficiaries, 1999–2014

Abstract: Background With over a decade of directed efforts to reduce sex and racial differences in coronary artery bypass grafting (CABG) utilization, and post‐CABG outcomes, we sought to evaluate how the u...

Comparison of Physician Visual Assessment With Quantitative Coronary Angiography in Assessment of Stenosis Severity in China.

Abstract: Importance Although physician visual assessment (PVA) of stenosis severity is a standard clinical practice to support decisions for coronary revascularization, there are concerns about its accuracy. Objective To compare PVA with quantitative coronary angiography (QCA) as a means of assessing stenosis severity among patients undergoing percutaneous coronary intervention (PCI) in China. Design, Setting, and Participants A cross-sectional study (2012-2013) of a random subset of 1295 patients from the China Patient-centered Evaluative Assessment of Cardiac Events (PEACE) Prospective PCI Study was carried out. The PEACE Prospective PCI study recruited a consecutive sample of patients undergoing PCI at 35 hospitals in 18 provinces of China. The coronary angiograms of this subset of participants were reviewed using QCA by 2 independent core laboratories blinded to PVA readings. Main Outcomes and Measures Differences between PVA and QCA assessments of stenosis severity for lesions for which PCI was performed and variation of these differences among hospitals and physicians, stratified by the diagnosis of acute myocardial infarction (AMI). Results In patients without AMI, the mean (SD) age was 62 (10) years, and 217 (31.5%) were women; in patients with AMI, the mean (SD) age was 60 (11) years, and 153 (25.2%) were women. The mean (SD) percent diameter stenosis by PVA was 16.0% (11.5%) greater than that by QCA in patients without AMI and 10.2% (12.3%) in those with AMI ( P Conclusions and Relevance For coronary lesions treated with PCI in China, PVA reported substantially higher readings of stenosis severity than QCA, with large variation across hospitals and physicians. These findings highlight the need to improve the accuracy of information used to guide treatment decisions in catheterization laboratories.

Is Posthospital Syndrome a Result of Hospitalization-Induced Allostatic Overload?

Abstract: After discharge from the hospital, patients face a transient period of generalized susceptibility to disease as well as an elevated risk for adverse events, including hospital readmission and death. The term posthospital syndrome (PHS) has been used to describe this time of enhanced vulnerability. Based on data from bench to bedside, this narrative review examines the hypothesis that hospitalrelated allostatic overload is a plausible etiology of PHS. Resulting from extended exposure to stress, allostatic overload is a maladaptive state driven by overuse and dysregulation of the hypothalamic-pituitary-adrenal axis and the autonomic nervous system that ultimately generates pathophysiologic consequences to multiple organ systems. Markers of allostatic overload, including elevated levels of cortisol, catecholamines, and inflammatory markers, have been associated with adverse outcomes after hospital discharge. Based on the evidence, we suggest a possible mechanism for postdischarge vulnerability, encourage critical contemplation of traditional hospital environments, and suggest interventions that might improve outcomes.

Ventricular septal rupture complicating acute myocardial infarction: Incidence, treatment, and outcomes among medicare beneficiaries 1999-2014.

Abstract: OBJECTIVES The present study was designed to assess whether the incidence and outcomes of VSR-AMI have changed in the era of timely primary PCI. BACKGROUND Ventricular septal rupture (VSR) is a rare but frequently fatal complication of acute myocardial infarction (AMI). METHODS We conducted a retrospective cohort study of all Medicare fee-for-service beneficiaries from 1999 to 2014 to examine trends in the incidence, surgical and percutaneous repair, and 30-day and 1-year mortality of VSR-AMI. RESULTS The annual incidence of VSR-AMI hospitalization declined by 41.6% from 197 patients per 100,000 AMIs in 1999 to 115 patients per 100,000 AMIs in 2014 (P < 0.001). The 30-day VSR-AMI repair rate decreased from 49.9% in 1999 to 33.3% in 2014 (P < 0.001). In 2014, 82.9% of repairs were performed surgically and 17.1% percutaneously. VSR-AMI mortality rates were high (60.2% at 30 days; 68.5% at 1 year) and changed minimally over the study period with adjusted 30-day mortality per year Odds Ratio (OR) 0.99 (95% confidence interval [CI] 0.98-1.01) and adjusted 1-year mortality per year OR 0.98 (95% CI 0.97-1.00). Across the 16 years of data, unadjusted mortality rates were lower in patients undergoing repair than in unrepaired patients at 30 days (mean 51.7% and 65.7%, P ≤ 0.01) and 1 year (mean 62.0% and 72.8%, P < 0.01). CONCLUSIONS In the era of increased timely primary PCI, the incidence of VSR-AMI hospitalization declined but its associated mortality rate remained high. Rates of VSR repair decreased from 1999 to 2014 despite increased use of percutaneous repair.

Association of Racial and Socioeconomic Disparities With Outcomes Among Patients Hospitalized With Acute Myocardial Infarction, Heart Failure, and Pneumonia: An Analysis of Within- and Between-Hospital Variation.

Abstract: Importance Although studies have described differences in hospital outcomes by patient race and socioeconomic status, it is not clear whether such disparities are driven by hospitals themselves or by broader systemic effects. Objective To determine patterns of racial and socioeconomic disparities in outcomes within and between hospitals for patients with acute myocardial infarction, heart failure, and pneumonia. Design, Setting, and Participants Retrospective cohort study initiated before February 2013, with additional analyses conducted during the peer-review process. Hospitals in the United States treating at least 25 Medicare fee-for-service beneficiaries aged 65 years or older in each race (ie, black and white) and neighborhood income level (ie, higher income and lower income) for acute myocardial infarction, heart failure, and pneumonia between 2009 and 2011 were included. Main Outcomes and Measures For within-hospital analyses, risk-standardized mortality rates and risk-standardized readmission rates for race and neighborhood income subgroups were calculated at each hospital. The corresponding ratios using intraclass correlation coefficients were then compared. For between-hospital analyses, risk-standardized rates were assessed according to hospitals’ proportion of patients in each subgroup. These analyses were performed for each of the 12 analysis cohorts reflecting the unique combinations of outcomes (mortality and readmission), demographics (race and neighborhood income), and conditions (acute myocardial infarction, heart failure, and pneumonia). Results Between 74% (3545 of 4810) and 91% (4136 of 4554) of US hospitals lacked sufficient racial and socioeconomic diversity to be included in this analysis, with the number of hospitals eligible for analysis varying among cohorts. The 12 analysis cohorts ranged in size from 418 to 1265 hospitals and from 144 417 to 703 324 patients. Within included hospitals, risk-standardized mortality rates tended to be lower among black patients (mean [SD] difference between risk-standardized mortality rates in black patients compared with white patients for acute myocardial infarction, −0.57 [1.1] [P = .47]; for heart failure, −4.7 [1.3] [P Conclusions and Relevance Hospital performance according to race and socioeconomic status was generally consistent within and between hospitals, even as there were overall differences in outcomes by race and neighborhood income. This finding indicates that disparities are likely to be systemic, rather than localized to particular hospitals.

Assessment of US Hospital Compliance With Regulations for Patients’ Requests for Medical Records

Abstract: Importance Although federal law has long promoted patients’ access to their protected health information, this access remains limited. Previous studies have demonstrated some issues in requesting release of medical records, but, to date, there has been no comprehensive review of the challenges that exist in all aspects of the request process. Objective To evaluate the current state of medical records request processes of US hospitals in terms of compliance with federal and state regulations and ease of patient access. Design, Setting, and Participants A cross-sectional study of medical records request processes was conducted between August 1 and December 7, 2017, in 83 top-ranked US hospitals with independent medical records request processes and medical records departments reachable by telephone. Hospitals were ranked as the top 20 hospitals for each of the 16 adult specialties in the 2016-2017US News & World ReportBest Hospitals National Rankings. Exposures Scripted interview with medical records departments in a single-blind, simulated patient experience. Main Outcomes and Measures Requestable information (entire medical record, laboratory test results, medical history and results of physical examination, discharge summaries, consultation reports, physician orders, and other), formats of release (pick up in person, mail, fax, email, CD, and online patient portal), costs, and request processing times, identified on medical records release authorization forms and through telephone calls with medical records departments. Results Among the 83 top-ranked US hospitals representing 29 states, there was discordance between information provided on authorization forms and that obtained from the simulated patient telephone calls in terms of requestable information, formats of release, and costs. On the forms, as few as 9 hospitals (11%) provided the option of selecting 1 of the categories of information and only 44 hospitals (53%) provided patients the option to acquire the entire medical record. On telephone calls, all 83 hospitals stated that they were able to release entire medical records to patients. There were discrepancies in information given in telephone calls vs on the forms between the formats hospitals stated that they could use to release information (69 [83%] vs 40 [48%] for pick up in person, 20 [24%] vs 14 [17%] for fax, 39 [47%] vs 27 [33%] for email, 55 [66%] vs 35 [42%] for CD, and 21 [25%] vs 33 [40%] for online patient portals), additionally demonstrating noncompliance with federal regulations in refusing to provide records in the format requested by the patient. There were 48 hospitals that had costs of release (as much as $541.50 for a 200-page record) above the federal recommendation of $6.50 for electronically maintained records. At least 6 of the hospitals (7%) were noncompliant with state requirements for processing times. Conclusions and Relevance The study revealed that there are discrepancies in the information provided to patients regarding the medical records release processes and noncompliance with federal and state regulations and recommendations. Policies focused on improving patient access may require stricter enforcement to ensure more transparent and less burdensome medical records request processes for patients.

Biomedical journal speed and efficiency: a cross-sectional pilot survey of author experiences

Abstract: Although the peer review process is believed to ensure scientific rigor, enhance research quality, and improve manuscript clarity, many investigators are concerned that the process is too slow, too expensive, too unreliable, and too static. In this feasibility study, we sought to survey corresponding authors of recently published clinical research studies on the speed and efficiency of the publication process. Web-based survey of corresponding authors of a 20% random sample of clinical research studies in MEDLINE-indexed journals with Ovid MEDLINE entry dates between December 1 and 15, 2016. Survey addressed perceived manuscript importance before first submission, approximate first submission and final acceptance dates, and total number of journal submissions, external peer reviews, external peer reviewers, and revisions requested, as well as whether authors would have considered publicly sharing their manuscript on an online platform instead of submitting to a peer-reviewed journal. Of 1780 surveys distributed, 27 corresponding authors opted out or requested that we stop emailing them and 149 emails failed (e.g., emails that bounced n = 64, returned with an away from office message n = 70, or were changed/incorrect n = 15), leaving 1604 respondents, of which 337 completed the survey (21.0%). Respondents and non-respondents were similar with respect to study type and publication journals’ impact factor, although non-respondent authors had more publications (p = 0.03). Among respondents, the median impact factor of the publications’ journal was 2.7 (interquartile range (IQR), 2.0–3.6) and corresponding authors’ median h-index and number of publications was 9 (IQR, 3–20) and 27 (IQR, 10–77), respectively. The median time from first submission to journal acceptance and publication was 5 months (IQR, 3–8) and 7 months (IQR, 5–12), respectively. Most respondents (62.0%, n = 209) rated the importance of their research as a 4 or 5 (5-point scale) prior to submission. Median number of journal submissions was 1 (IQR, 1–2), external peer reviews was 1 (IQR, 1–2), external peer reviewers was 3 (IQR, 2–4), and revisions requested was 1 (IQR, 1–1). Sharing manuscripts to a public online platform, instead of submitting to a peer-reviewed journal, would have been considered by 55.2% (n = 186) of respondents. Corresponding authors have high perceptions of their research and reported requiring few manuscript submissions prior to journal acceptance, most commonly by lower impact factor journals.

The digital transformation of medicine can revitalize the patient-clinician relationship.

Abstract: Health professionals within the medical community feel that the principles of humanism in medicine have not been a point of emphasis for information and computer technology in healthcare. There is concern that the electronic health record is eroding the patient-clinician relationship and distancing clinicians from their patients. New analytic technologies, on the contrary, by taking over repetitive and mundane tasks, can provide an avenue to make medical care more patient-centered by freeing clinicians’ time, and the time of the whole clinical care team, to engage with patients. Technology such as advanced speech recognition that optimizes clinicians’ workflow could revitalize the patient-clinician relationship and perhaps also improve clinician well-being. Digital phenotyping can gain invaluable additional data from patients using technology that is already used for personal reasons by the majority of patients. The digital transformation of healthcare has the potential to make healthcare more humane and personalized, however, several important steps are needed to avoid the pitfalls that have come with prior iterations of information technology in medicine such as a heightened emphasis on data security and transparency. Both patients and clinicians should be involved from the early stages of development of medical technologies to ensure that they are person-centric. Technologists and engineers developing healthcare technologies should have experiences with the delivery of healthcare and the lives of patients and clinicians. These steps are necessary to develop a common commitment to the design concept that technology and humane care are not mutually exclusive, and in fact, can be symbiotic.

Prediction of adverse events in patients undergoing major cardiovascular procedures

Abstract: Electronic health records (EHR) provide opportunities to leverage vast arrays of data to help prevent adverse events, improve patient outcomes, and reduce hospital costs. A postoperative complications prediction system is provided that extracts data from the EHR and creates features. An analytic engine then provides model accuracy, calibration, feature ranking, and personalized feature responses. The system allows clinicians to interpret the likelihood of an adverse event occurring, general causes for these events, and the contributing factors for each specific patient.

Implications of coronary artery calcium testing on risk stratification for lipid-lowering therapy according to the 2016 European Society of Cardiology recommendations: The MESA study:

Abstract: AimsThe European Society of Cardiology (ESC) guideline on cardiovascular risk assessment considers coronary artery calcium a class B indication for risk assessment. We evaluated the degree to which...

Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study.

Abstract: Mandatory trial registration, and later results reporting, were proposed to mitigate selective clinical trial publication and outcome reporting. The Food and Drug Administration (FDA) Amendments Act (FDAAA) was enacted by Congress on September 27, 2007, requiring the registration of all non-phase I clinical trials involving FDA-regulated medical interventions and results reporting for approved drugs. The association between FDAAA enactment and the registration, results reporting, and publication bias of neuropsychiatric trials has not been studied. We conducted a retrospective cohort study of all efficacy trials supporting FDA new drug approvals between 2005 to 2014 for neuropsychiatric indications. Trials were categorized as pre- or post-FDAAA based on initiation and/or completion dates. The main outcomes were the proportions of trials registered and reporting results in ClinicalTrials.gov, and the degree of publication bias, estimated using the relative risks pre- and post-FDAAA of both the publication of positive vs non-positive trials, as well as of publication of positive vs non-positive trials without misleading interpretations. Registration and results reporting proportions were compared pre- and post-FDAAA using the two-tailed Fisher exact test, and the degrees of publication bias were compared by calculating the ratio of relative risks (RRR) for each period. The FDA approved 37 new drugs for neuropsychiatric indications between 2005 and 2014 on the basis of 142 efficacy trials, of which 101 were pre-FDAAA and 41 post-FDAAA. Post-FDAAA trials were significantly more likely to be registered (100% vs 64%; p < 0.001) and report results (100% vs 10%; p < 0.001) than pre-FDAAA trials. Pre-FDAAA, positive trials were more likely to be published (relative risk [RR] = 1.52; 95% confidence interval [CI] = 1.17–1.99; p = 0.002) and published without misleading interpretations (RR = 2.47; CI = 1.57–3.73; p < 0.001) than those with non-positive results. In contrast, post-FDAAA positive trials were equally likely to have been published (RR = 1; CI = 1–1, p = NA) and published without misleading interpretations (RR = 1.20; CI = 0.84–1.72; p = 0.30). The likelihood of publication bias pre-FDAAA vs post-FDAAA was greater for positive vs non-positive trials (RRR = 1.52; CI = 1.16–1.99; p = 0.002) and for publication without misleading interpretations (RRR = 2.06, CI = 1.17–3.61, p = 0.01). The enactment of FDAAA was followed by significantly higher proportions of trials that were registered and reporting results on ClinicalTrials.gov and significantly lower degrees of publication bias among trials supporting recent FDA approval of drugs for neuropsychiatric indications.

Trends in acute pericarditis hospitalizations and outcomes among the elderly in the USA, 1999-2012.

Abstract: Aims The elderly are at risk of pericarditis from conditions such as malignancy, renal disease, and after cardiac surgery. However, the burden of pericarditis and, especially, the long-term outcomes associated with pericarditis have not been described before among the elderly. Methods and results We examined hospitalization rates; in-hospital, 30-day, and 1-year all-cause mortality rates; all-cause 30-day readmission rates; length of stay and health care expenditure for Medicare beneficiaries aged 65 years or older with a principal discharge diagnosis of pericarditis from 1999 to 2012. A total of 45 504 hospitalizations were identified. The hospitalization rate for pericarditis remained stable at 26 per 100 000 person-years across the study period and was consistently higher among men and the oldest old. The adjusted all-cause 30-day mortality rates decreased from 7.6% [95% confidence interval (CI) 6.9-8.2] in 1999 to 5.7% (95% CI 4.5-7.1) in 2012 and all-cause 1-year mortality rates decreased from 19.7% (95% CI 18.8-20.8) in 1999 to 17.3% (95% CI 15.3-20) in 2011 respectively. The 30-day all-cause readmission rate remained unchanged at 18% across the study period. The length of stay ranged from a mean of 5.8 days in 1999 to 5.5 days in 2012. The consumer price index adjusted cost per hospitalization increased from $8404 in 1999 to $9982 in 2012. Conclusion The hospitalization rate for acute pericarditis has remained unchanged among older adults. Although mortality rates associated with pericarditis have improved, hospitalization for pericarditis continues to signal a high risk of dying within a year.

Emergency Department Volume and Outcomes for Patients After Chest Pain Assessment.

Abstract: Background: Chest pain is one of the most common reasons for emergency department (ED) visits in developed countries. Whether higher volume EDs have better outcomes, specifically for patients with ...