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Additional file 1.

Additional file 6: Supplement 6. Trial registration data of the LIGHT-ACD trial.

Additional file 3: Supplement 3. Example of CDSS recommendation.

Additional file 1: Supplement 1. Stratification factors for each stage in site randomization of LIGHT trial.

Additional file 4: Supplement 4. Specifications of guideline-based antihypertensive treatment.

BackgroundReports on medium and long-term sequelae of SARS-CoV-2 infections largely lack quantification of incidence and relative risk. We describe the rationale and methods of the Innovative Support for Patients with SARS-CoV-2 Registry (INSPIRE) that combines patient-reported outcomes with data from digital health records to understand predictors and impacts of SARS-CoV-2 infection.MethodsINSPIRE is a prospective, multicenter, longitudinal study of individuals with symptoms of SARS-CoV-2 infection in eight regions across the US. Adults are eligible for enrollment if they are fluent in English or Spanish, reported symptoms suggestive of acute SARS-CoV-2 infection, and if they are within 42 days of having a SARS-CoV-2 viral test (i.e., nucleic acid amplification test or antigen test), regardless of test results. Recruitment occurs in-person, by phone or email, and through online advertisement. A secure online platform is used to facilitate the collation of consent-related materials, digital health records, and responses to self-administered surveys. Participants are followed for up to 18 months, with patient-reported outcomes collected every three months via survey and linked to concurrent digital health data; follow-up includes no in-person involvement. Our planned enrollment is 4,800 participants, including 2,400 SARS-CoV-2 positive and 2,400 SARS-CoV-2 negative participants (as a concurrent comparison group). These data will allow assessment of longitudinal outcomes from SARS-CoV-2 infection and comparison of the relative risk of outcomes in individuals with and without infection. Patient-reported outcomes include self-reported health function and status, as well as clinical outcomes including health system encounters and new diagnoses.ResultsParticipating sites obtained institutional review board approval. Enrollment and follow-up are ongoing.ConclusionsThis study will characterize medium and long-term sequelae of SARS-CoV-2 infection among a diverse population, predictors of sequelae, and their relative risk compared to persons with similar symptomatology but without SARS-CoV-2 infection. These data may inform clinical interventions for individuals with sequelae of SARS-CoV-2 infection.

Additional file 5: Supplement 5. Trial registration data of the LIGHT trial.

Additional file 2.

Additional file 2: Supplement 2. Specification of hypertension visits.

[Figure: see text].

IMPORTANCE: Short-term outcomes after acute myocardial infarction (AMI) have improved, but little is known about longer-term outcomes. OBJECTIVE: To evaluate trends in 10-year all-cause mortality and hospitalization for recurrent AMI by demographic subgroups and examine the association between recurrence and mortality. DESIGN, SETTING, AND PARTICIPANTS: Medicare fee-for-service beneficiaries who survived after AMI from 1995 to 2019. Subgroups were defined by age, sex, race, dual Medicare-Medicaid–eligible status, and residence in health priority areas (geographic areas with persistently high adjusted mortality and hospitalization rates). Data were analyzed from October 2020 to February 2022. EXPOSURE: Medicare fee-for-service beneficiaries who survived an AMI. MAIN OUTCOMES AND MEASURES: Ten-year all-cause mortality and hospitalization for recurrent AMI, beginning 30 days from the index AMI admission. RESULTS: Of an included 3 982 266 AMI survivors, 1 952 450 (49.0%) were female, and the mean (SD) age was 78.0 (7.4) years. Ten-year mortality and recurrent AMI rates were 72.7% (95% CI, 72.6-72.7) and 27.1% (95% CI, 27.0-27.2), respectively. Adjusted annual reductions were 1.5% (95% CI, 1.4-1.5) for mortality and 2.7% (95% CI, 2.6-2.7) for recurrence. In subgroup analyses balancing patient characteristics, hazard ratios (HRs) for mortality and recurrence were 1.13 (95% CI, 1.12-1.13) and 1.07 (95% CI, 1.06-1.07), respectively, for men vs women; 1.05 (95% CI, 1.05-1.06) and 1.08 (95% CI, 1.07-1.09) for Black vs White patients; 0.96 (95% CI, 0.95-0.96) and 1.00 (95% CI, 1.00-1.01) for other race (including American Indian and Alaska Native, Asian, Hispanic, other race or ethnicity, and unreported) vs White patients; 1.24 (95% CI, 1.24-1.24) and 1.21 (95% CI, 1.20-1.21) for dual Medicare-Medicaid–eligible vs non–dual Medicare-Medicaid–eligible patients; and 1.06 (95% CI, 1.06-1.07) and 1.00 (95% CI, 1.00-1.01) for patients in health priority areas vs other areas. For patients hospitalized in 2007 to 2009, the last 3 years for which full 10-year follow-up data were available, 10-year mortality risk was 13.9% lower than for those hospitalized in 1995 to 1997 (adjusted HR, 0.86; 95% CI, 0.85-0.87) and 10-year recurrence risk was 22.5% lower (adjusted HR, 0.77; 95% CI, 0.76-0.78). Mortality within 10 years after the initial AMI was higher for patients with a recurrent AMI (80.6%; 95% CI, 80.5-80.7) vs those without recurrence (72.4%; 95% CI, 72.3-72.5). CONCLUSIONS AND RELEVANCE: In this study, 10-year mortality and hospitalization for recurrence rates improved over the last decades for patients who survived the acute period of AMI. There were marked differences in outcomes and temporal trends across demographic subgroups, emphasizing the urgent need for prioritization of efforts to reduce inequities in long-term outcomes.

Background Many communities have implemented systems of regionalized care to improve access to timely care for patients with ST-segment-elevation myocardial infarction. However, patients who are ultimately diagnosed with non-ST-segment-elevation myocardial infarctions (NSTEMIs) may also be affected, and the impact of regionalization programs on NSTEMI treatment and outcomes is unknown. We set out to determine the effects of ST-segment-elevation myocardial infarction regionalization schemes on treatment and outcomes of patients diagnosed with NSTEMIs. Methods and Results The cohort included all patients receiving care in emergency departments diagnosed with an NSTEMI at all nonfederal hospitals in California from January 1, 2005 to September 30, 2015. Data were analyzed using a difference-in-differences approach. The main outcomes were 1-year mortality and angiography within 3days of the index admission. A total of 293589 patients with NSTEMIs received care in regionalized and nonregionalized communities. Over the study period, rates of early angiography increased by 0.5 and mortality decreased by 0.9 percentage points per year among the overall population (95% CI, 0.4-0.6 and -1.0 to -0.8, respectively). Regionalization was not associated with early angiography (-0.5%; 95% CI, -1.1 to 0.1) or death (0.2%; 95% CI, -0.3 to 0.8). Conclusions ST-segment-elevation myocardial infarction regionalization programs were not statistically associated with changes in guideline-recommended early angiography or changes in risk of death for patients with NSTEMI. Increases in the proportion of patients with NSTEMI who underwent guideline-directed angiography and decreases in risk of mortality were accounted for by secular trends unrelated to regionalization policies.

Supplementary Material for this article is available at https://www.ahajournals.org/doi/suppl/10.1161/JAHA.120.016932 17 USC 105 interim-entered record; under review. 17 USC 105 interim-entered record; under review. The article of record as published may be found at https://doi.org/10.1161/JAHA.120.016932 Background: Many communities have implemented systems of regionalized care to improve access to timely care for patients with ST‐segment–elevation myocardial infarction. However, patients who are ultimately diagnosed with non–ST‐segment–elevation myocardial infarctions (NSTEMIs) may also be affected, and the impact of regionalization programs on NSTEMI treatment and outcomes is unknown. We set out to determine the effects of ST‐segment–elevation myocardial infarction regionalization schemes on treatment and outcomes of patients diagnosed with NSTEMIs. Methods and Results: The cohort included all patients receiving care in emergency departments diagnosed with an NSTEMI at all nonfederal hospitals in California from January 1, 2005 to September 30, 2015. Data were analyzed using a difference‐in‐differences approach. The main outcomes were 1‐year mortality and angiography within 3 days of the index admission. A total of 293 589 patients with NSTEMIs received care in regionalized and nonregionalized communities. Over the study period, rates of early angiography increased by 0.5 and mortality decreased by 0.9 percentage points per year among the overall population (95% CI, 0.4–0.6 and −1.0 to −0.8, respectively). Regionalization was not associated with early angiography (−0.5%; 95% CI, −1.1 to 0.1) or death (0.2%; 95% CI, −0.3 to 0.8). Conclusions: ST‐segment–elevation myocardial infarction regionalization programs were not statistically associated with changes in guideline‐recommended early angiography or changes in risk of death for patients with NSTEMI. Increases in the proportion of patients with NSTEMI who underwent guideline‐directed angiography and decreases in risk of mortality were accounted for by secular trends unrelated to regionalization policies. Research reported in this publication was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award No. R01HL134182 for Drs Hsia and Montoy, and R01HL114822 for Drs Hsia and Shen.

ObjectivesThis study sought to evaluate the association and burden of coronary artery calcium (CAC) with long-term, cause-specific mortality across the spectrum of baseline risk.BackgroundAlthough CAC is a known predictor of short-term, all-cause mortality, data on long-term and cause-specific mortality are inadequate.MethodsThe CAC Consortium cohort is a multicenter cohort of 66,636 participants without coronary heart disease (CHD) who underwent CAC testing. The following risk factors (RFs) were considered: 1) current cigarette smoking; 2) dyslipidemia; 3) diabetes mellitus; 4) hypertension; and 5) family history of CHD.ResultsDuring the 12.5-years median follow-up, 3,158 (4.7%) deaths occurred; 32% were cardiovascular disease (CVD) deaths. Participants with CAC scores ≥400 had a significantly increased risk for CHD and CVD mortality (hazard ratio [HR]: 5.44; 95% confidence interval [CI]: 3.88 to 7.62; and HR: 4.15; 95% CI: 3.29 to 5.22, respectively) compared with CAC of 0. Participants with ≥3 RFs had a smaller increased risk for CHD and CVD mortality (HR: 2.09; 95% CI: 1.52 to 2.85; and HR: 1.84; 95% CI: 1.46 to 2.31, respectively) compared with those without RFs. Across RF strata, CAC added prognostic information. For example, participants without RFs but with CAC ≥400 had significantly higher all-cause, non-CVD, CVD, and CHD mortality rates compared with participants with ≥3 RFs and CAC of 0.ConclusionsAcross the spectrum of RF burden, a higher CAC score was strongly associated with long-term, all-cause mortality and a greater proportion of deaths due to CVD and CHD. Absence of CAC identified people with a low risk over 12 years of follow-up, with most deaths being non-CVD in nature, regardless of RF burden.

Coronavirus disease-2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), may predispose patients to thrombotic disease, both in the venous and arterial circulations, because of excessive inflammation, platelet activation, endothelial dysfunction, and stasis. In addition, many patients receiving antithrombotic therapy for thrombotic disease may develop COVID-19, which can have implications for choice, dosing, and laboratory monitoring of antithrombotic therapy. Moreover, during a time with much focus on COVID-19, it is critical to consider how to optimize the available technology to care for patients without COVID-19 who have thrombotic disease. Herein, the authors review the current understanding of the pathogenesis, epidemiology, management, and outcomes of patients with COVID-19 who develop venous or arterial thrombosis, of those with pre-existing thrombotic disease who develop COVID-19, or those who need prevention or care for their thrombotic disease during the COVID-19 pandemic.

Supplemental material, Supplementary_File for Where Skilled Nursing Facility Residents Get Acute Care: Is the Emergency Department the Medical Home? by Arjun K. Venkatesh, Cameron J. Gettel, Hao Mei, Shih-Chuan Chou, Craig Rothenberg, Shu-Ling Liu, Gail D’Onofrio, ZhenQiu Lin and Harlan M. Krumholz in Journal of Applied Gerontology

Additional file 1: Figure A1. Monthly cohort definition for AMI, HF or Pneumonia Readmissions and Observation Stays (Pg.2). Figure A2. Hierarchy for multiple post-discharge care events (Pg. 2). Table A1. Cumulative numbers and percentages of final action inpatient claims uploaded to the IDR for all conditions with a discharge date in January 2013 and July 2013 (as of December 2014) (Pg.3). Figure A3: Modeling approach (Pg.3). Figure A4. Timing of calculating monthly outcomes (Pg.4). Table A2. Final model specification for prediction of number of admissions, readmission rate, and observation-stay rate in AMI cohort (Pg.4). Table A3: Specifications of the final real-time reporting models for Heart failure and pneumonia (Pg.6). Table A4: Results of look-back validation where we compare the rates estimated (for the months July 2016 through December 2016) in February 2017 using RTR models with the final rates later observed using data downloaded from the IDR in February 2018 for AMI, HF and Pneumonia (Pg.7). Figure A5. Prediction and look-back validation for heart failure admission, readmission and observation stays (July 2016–December 2016) (Pg.8). Figure A6. Prediction and look-back validation for pneumonia admission, readmission and observation stays (July 2016–December 2016 (Pg.9).

BACKGROUND:Uncertainty remains about the optimal monotherapy for hypertension, with current guidelines recommending any primary agent among the first-line drug classes thiazide or thiazide-like diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, dihydropyridine calcium channel blockers, and non-dihydropyridine calcium channel blockers, in the absence of comorbid indications. Randomised trials have not further refined this choice. METHODS:We developed a comprehensive framework for real-world evidence that enables comparative effectiveness and safety evaluation across many drugs and outcomes from observational data encompassing millions of patients, while minimising inherent bias. Using this framework, we did a systematic, large-scale study under a new-user cohort design to estimate the relative risks of three primary (acute myocardial infarction, hospitalisation for heart failure, and stroke) and six secondary effectiveness and 46 safety outcomes comparing all first-line classes across a global network of six administrative claims and three electronic health record databases. The framework addressed residual confounding, publication bias, and p-hacking using large-scale propensity adjustment, a large set of control outcomes, and full disclosure of hypotheses tested. FINDINGS:Using 4·9 million patients, we generated 22 000 calibrated, propensity-score-adjusted hazard ratios (HRs) comparing all classes and outcomes across databases. Most estimates revealed no effectiveness differences between classes; however, thiazide or thiazide-like diuretics showed better primary effectiveness than angiotensin-converting enzyme inhibitors: acute myocardial infarction (HR 0·84, 95% CI 0·75-0·95), hospitalisation for heart failure (0·83, 0·74-0·95), and stroke (0·83, 0·74-0·95) risk while on initial treatment. Safety profiles also favoured thiazide or thiazide-like diuretics over angiotensin-converting enzyme inhibitors. The non-dihydropyridine calcium channel blockers were significantly inferior to the other four classes. INTERPRETATION:This comprehensive framework introduces a new way of doing observational health-care science at scale. The approach supports equivalence between drug classes for initiating monotherapy for hypertension-in keeping with current guidelines, with the exception of thiazide or thiazide-like diuretics superiority to angiotensin-converting enzyme inhibitors and the inferiority of non-dihydropyridine calcium channel blockers. FUNDING:US National Science Foundation, US National Institutes of Health, Janssen Research & Development, IQVIA, South Korean Ministry of Health & Welfare, Australian National Health and Medical Research Council.

BackgroundThe relative prevalence and clinical importance of monogenic mutations related to familial hypercholesterolemia and of high polygenic score (cumulative impact of many common variants) pathways for early-onset myocardial infarction remain uncertain. Whole-genome sequencing enables simultaneous ascertainment of both monogenic mutations and polygenic score for each individual.MethodsWe performed deep-coverage whole-genome sequencing of 2081 patients from 4 racial subgroups hospitalized in the United States with early-onset myocardial infarction (age ≤55 years) recruited with a 2:1 female-to-male enrollment design. We compared these genomes with those of 3761 population-based control subjects. We first identified individuals with a rare, monogenic mutation related to familial hypercholesterolemia. Second, we calculated a recently developed polygenic score of 6.6 million common DNA variants to quantify the cumulative susceptibility conferred by common variants. We defined high polygenic score as the top 5% of the control distribution because this cutoff has previously been shown to confer similar risk to that of familial hypercholesterolemia mutations.ResultsThe mean age of the 2081 patients presenting with early-onset myocardial infarction was 48 years, and 66% were female. A familial hypercholesterolemia mutation was present in 36 of these patients (1.7%) and was associated with a 3.8-fold (95% CI, 2.1-6.8; P3-fold increased odds of early-onset myocardial infarction. However, high polygenic score has a 10-fold higher prevalence among patients presents with early-onset myocardial infarction.Clinical trial registrationURL: https://www.clinicaltrials.gov . Unique identifier: NCT00597922.

Publisher's version (útgefin grein), Aims: There is debate about the optimum algorithm for cardiovascular disease (CVD) risk estimation. We conducted head-to-head comparisons of four algorithms recommended by primary prevention guidelines, before and after 'recalibration', a method that adapts risk algorithms to take account of differences in the risk characteristics of the populations being studied. Methods and results: Using individual-participant data on 360 737 participants without CVD at baseline in 86 prospective studies from 22 countries, we compared the Framingham risk score (FRS), Systematic COronary Risk Evaluation (SCORE), pooled cohort equations (PCE), and Reynolds risk score (RRS). We calculated measures of risk discrimination and calibration, and modelled clinical implications of initiating statin therapy in people judged to be at 'high' 10 year CVD risk. Original risk algorithms were recalibrated using the risk factor profile and CVD incidence of target populations. The four algorithms had similar risk discrimination. Before recalibration, FRS, SCORE, and PCE over-predicted CVD risk on average by 10%, 52%, and 41%, respectively, whereas RRS under-predicted by 10%. Original versions of algorithms classified 29-39% of individuals aged ≥40 years as high risk. By contrast, recalibration reduced this proportion to 22-24% for every algorithm. We estimated that to prevent one CVD event, it would be necessary to initiate statin therapy in 44-51 such individuals using original algorithms, in contrast to 37-39 individuals with recalibrated algorithms. Conclusion: Before recalibration, the clinical performance of four widely used CVD risk algorithms varied substantially. By contrast, simple recalibration nearly equalized their performance and improved modelled targeting of preventive action to clinical need., The work of the co-ordinating centre was funded by the UK Medical Research Council (G0800270), British Heart Foundation (SP/09/ 002), British Heart Foundation Cambridge Cardiovascular Centre of Excellence, UK National Institute for Health Research Cambridge Biomedical Research Centre, European Research Council (268834), and European Commission Framework Programme 7 (HEALTH-F2-2012-279233). The Emerging Risk Factor Collaboration’s website https://www.phpc.cam.ac.uk/ceu/erfc/list-of-studies/ has compiled a list provided by investigators of some of the funders of the component studies in this analysis. I.W. was supported by the Medical Research Council Unit Programme MC_UU_12023/21. M.K. is supported by the Netherlands Organization for Scientific Research (NWO) Veni grant (Veni, 91616079). J.P. is supported by Erasmus Mundus Western Balkans (ERAWEB), a project funded by the European Commission.

Cardiovascular disorders account for nearly 1 in 3 deaths in the United States. Care for these disorders are often determined during visits to acute care facilities, such as hospitals. While the length of stay in these settings represents just a small proportion of patients' lives, they account for a disproportionately large amount of decision making. To overcome this bias towards data from acute care settings, there is a need for longitudinal monitoring in patients with cardiovascular disorders. Longitudinal monitoring can provide a more comprehensive picture of patient health, allowing for more informed decision making. This work surveys the current field of sensing technologies and machine learning analytics that exist in the field of remote monitoring for cardiovascular disorders. We highlight three primary needs in the design of new smart health technologies: 1) the need for sensing technology that can track longitudinal trends in signs and symptoms of the cardiovascular disorder despite potentially infrequent, noisy, or missing data measurements; 2) the need for new analytic techniques that model data captured in a longitudinal, continual fashion to aid in the development of new risk prediction techniques and in tracking disease progression; and 3) the need for machine learning techniques that are personalized and interpretable, allowing for advancements in shared clinical decision making. We highlight these needs based upon the current state-of-the-art in smart health technologies and analytics and discuss the ample opportunities that exist in addressing all three needs in the development of smart health technologies and analytics applied to the field of cardiovascular disorders and care., Comment: 32 pages, 3 figures, to be submitted to ACM Transactions on Computing for Healthcare (HEALTH), Special Issue on Wearable Technologies for Smart Health 2019

BackgroundPhysicians "purchase" many health care services on behalf of patients yet remain largely unaware of the costs of these services. Electronic health record (EHR) cost displays may facilitate cost-conscious ordering of health services.ObjectiveTo determine whether displaying hospital lab and imaging order costs is associated with changes in the number and costs of orders placed.DesignQuasi-experimental study.ParticipantsAll patients with inpatient or observation encounters across a multi-site health system from April 2013 to October 2015.InterventionDisplay of order costs, based on Medicare fee schedules, in the EHR for 1032 lab tests and 1329 imaging tests.Main measuresOutcomes for both lab and imaging orders were (1) whether an order was placed during a hospital encounter, (2) whether an order was placed on a given patient-day, (3) number of orders placed per patient-day, and (4) cost of orders placed per patient-day.Key resultsDuring the lab and imaging study periods, there were 248,214 and 258,267 encounters, respectively. Cost display implementation was associated with a decreased odds of any lab or imaging being ordered during the encounter (lab adjusted odds ratio [AOR] = 0.97, p= .01; imaging AOR = 0.97, p&nbsp

Objective: To (1) demonstrate the implementation of a data science platform built on open-source technology within a large, academic healthcare system and (2) describe two computational healthcare applications built on such a platform. Materials and Methods: A data science platform based on several open source technologies was deployed to support real-time, big data workloads. Data acquisition workflows for Apache Storm and NiFi were developed in Java and Python to capture patient monitoring and laboratory data for downstream analytics. Results: The use of emerging data management approaches along with open-source technologies such as Hadoop can be used to create integrated data lakes to store large, real-time data sets. This infrastructure also provides a robust analytics platform where healthcare and biomedical research data can be analyzed in near real-time for precision medicine and computational healthcare use cases. Discussion: The implementation and use of integrated data science platforms offer organizations the opportunity to combine traditional data sets, including data from the electronic health record, with emerging big data sources, such as continuous patient monitoring and real-time laboratory results. These platforms can enable cost-effective and scalable analytics for the information that will be key to the delivery of precision medicine initiatives. Conclusion: Organizations that can take advantage of the technical advances found in data science platforms will have the opportunity to provide comprehensive access to healthcare data for computational healthcare and precision medicine research., Comment: 8 pages, 4 figures, 1 table

The governance of data used for biomedical research and clinical trials is an important requirement for generating accurate results. To improve the visibility of data quality and analysis, we developed TrialChain, a blockchain-based platform that can be used to validate data integrity from large, biomedical research studies. We implemented a private blockchain using the MultiChain platform and integrated it with a data science platform deployed within a large research center. An administrative web application was built with Python to manage the platform, which was built with a microservice architecture using Docker. The TrialChain platform was integrated during data acquisition into our existing data science platform. Using NiFi, data were hashed and logged within the local blockchain infrastructure. To provide public validation, the local blockchain state was periodically synchronized to the public Ethereum network. The use of a combined private/public blockchain platform allows for both public validation of results while maintaining additional security and lower cost for blockchain transactions. Original data and modifications due to downstream analysis can be logged within TrialChain and data assets or results can be rapidly validated when needed using API calls to the platform. The TrialChain platform provides a data governance solution to audit the acquisition and analysis of biomedical research data. The platform provides cryptographic assurance of data authenticity and can also be used to document data analysis.

Young women with acute myocardial infarction (AMI) have higher mortality risk than similarly aged men. An adverse lipid profile is an important risk factor for cardiovascular outcomes after AMI, but little is known about whether young women with AMI have a higher-risk lipid pattern than men. We characterized sex differences in lipid profiles and treatment utilization among young adults with AMI.

IntroductionComplex coronary artery disease (left main and three-vessel disease) carries high risks of adverse events and cost burden. However, in China, little is known about which patients are directed toward which treatment strategies and what outcomes are being achieved.Methods and analysisUsing the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) research network, this prospective study of three-Vessel Disease, the China PEACE-3VD study, has a plan to consecutively register over 4000 patients with a diagnosis of 3VD and/or left-main disease by elective coronary angiography at 24 large cardiovascular centres in China. We centrally conducted medical record abstraction and SYNTAX Score calculation for all registered patients. The sites invited patients to the prospective cohort, and conducted 1-year follow-up on major events, including cardiac events, symptoms, secondary prevention and quality of life. The estimated entire sample size of eligible patients of 4000 was determined based on both feasibility and consideration of adequate statistical precision for describing the treatment decisions, guidelines adherence and appropriateness of treatment for patients with complex coronary artery diseases. The study is designed to investigate patient, clinician and hospital factors associated with each treatment strategy (percutaneous coronary intervention, coronary artery bypass grafting or medical therapy) as well as appropriateness of treatment choice, current guideline compliance and patient-reported outcomes for patients with complex coronary artery disease in large cardiovascular centres in China, as a foundation for enhanced knowledge in the field and to assist quality improvement initiatives.Ethics and disseminationThe study protocol was approved by the ethics committee at the China National Center for Cardiovascular Diseases. Findings will be shared with participating hospitals, policymakers and the academic community, to promote quality monitoring, quality improvement and the efficient allocation, and use of coronary revascularisation procedures in China.Trial registration numberNCT01625312; Pre-results.

BackgroundGuidelines for heart failure (HF) recommend prescription of guideline-directed medical therapy before hospital discharge; some of these therapies are included in publicly reported performance measures. The burden of new medications for individual patients has not been described.Methods and resultsWe used Get With The Guidelines-HF registry data from 2008 to 2013 to characterize prescribing, indications, and contraindications for angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, β-blockers, aldosterone antagonists, hydralazine/isosorbide dinitrate, and anticoagulants. The difference between a patient's medication regimen at hospital admission and that recommended by HF quality measures at discharge was calculated. Among 158 922 patients from 271 hospitals with a primary discharge diagnosis of HF, initiation of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers was indicated in 18.1% of all patients (55.5% of those eligible at discharge were not receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blockers at admission), β-blockers in 20.3% (50.5% of eligible), aldosterone antagonists in 24.1% (87.4% of eligible), hydralazine/isosorbide dinitrate in 8.6% (93.1% of eligible), and anticoagulants in 18.0% (58.0% of eligible). Cumulatively, 0.4% of patients were eligible for 5 new medication groups, 4.1% for 4 new medication groups, 9.4% for 3 new medication groups, 10.1% for 2 new medication groups, and 22.7% for 1 new medication group; 15.0% were not eligible for new medications because of adequate prescribing at admission; and 38.4% were not eligible for any medications recommended by HF quality measures. Compared with newly indicated medications (mean, 1.45 ± 1.23), actual new prescriptions were lower (mean, 1.16 ± 1.00).ConclusionsA quarter of patients hospitalized with HF need to start >1 medication to meet HF quality measures. Systems for addressing medication initiation and managing polypharmacy are central to HF transitional care.

BackgroundPrior claims analyses suggest that the use of intravenous inotropic therapy for patients hospitalized with heart failure varies substantially by hospital. Whether differences in the clinical characteristics of the patients explain observed differences in the use of inotropic therapy is not known.Methods and resultsWe sought to characterize institutional variation in inotrope use among patients hospitalized with heart failure before and after accounting for clinical factors of patients. Hierarchical generalized linear regression models estimated risk-standardized hospital-level rates of inotrope use within 209 hospitals participating in Get With The Guidelines-Heart Failure (GWTG-HF) registry between 2005 and 2011. The association between risk-standardized rates of inotrope use and clinical outcomes was determined. Overall, an inotropic agent was administered in 7691 of 126 564 (6.1%) heart failure hospitalizations: dobutamine 43%, dopamine 24%, milrinone 17%, or a combination 16%. Patterns of inotrope use were stable during the 7-year study period. Use of inotropes varied significantly between hospitals even after accounting for patient and hospital characteristics (median risk-standardized hospital rate, 5.9%; interquartile range, 3.7%-8.6%; range, 1.3%-32.9%). After adjusting for case-mix and hospital structural differences, model intraclass correlation indicated that 21% of the observed variation in inotrope use was potentially attributable to random hospital effects (ie, institutional preferences). Hospitals with higher risk-standardized inotrope use had modestly longer risk-standardized length of stay (P=0.005) but had no difference in risk-standardized inpatient mortality (P=0.12).ConclusionsUse of intravenous inotropic agents during hospitalization for heart failure varies significantly among US hospitals even after accounting for patient and hospital factors.

Objectives. We sought to 1) determine the proportion of appropriate elderly patients admitted to the hospital with unstable angina who are treated with aspirin and heparin; 2) identify patient factors associated with the Agency for Health Care Policy and Research (AHCPR) guideline-based use of aspirin and heparin; and 3) compare practice patterns and patient outcomes before and after publication of the AHCPR guidelines.Background. Improving the care of patients with unstable angina may provide immediate opportunities to mitigate the adverse consequences of unstable angina. However, despite the importance of this diagnosis, there is a paucity of information on the patterns of treatment and outcomes across diverse sites and recent trends in practice that have occurred, especially since the publication of the AHCPR practice guidelines.Methods. We performed a retrospective cohort study using data created from medical charts and administrative files. The sample included 300 consecutive patients admitted to one of three Connecticut hospitals in the period 1993 to 1994 and 150 consecutive patients admitted in 1995 with a principal discharge diagnosis of unstable angina or chest pain.Results. Of the 384 patients ≥65 years old who had no contraindications to aspirin on hospital admission, 276 (72%) received it. Of the 369 patients ≥65 years old who had no contraindications to heparin on admission, 88 (24%) received it. Among the 321 patients ≥65 years old who had no contraindications to aspirin at hospital discharge, 208 (65%) were prescribed it. When 1995 was compared with 1993 to 1994, the use of aspirin (odds ratio [OR] 2.3, 95% confidence interval [CI] 1.3 to 4.0) and heparin (OR 2.8, 95% CI 1.6 to 4.9) on hospital admission significantly increased, and the use of aspirin at discharge (OR 1.4, 95% CI 0.8 to 2.4) increased. Concomitantly, there was a significant reduction in 30-day readmission (OR 0.52, 95% CI 0.27 to 0.99).Conclusions. Our results indicate an improvement in the care and outcomes of elderly patients with unstable angina, but there remain opportunities for further improvement.

Objectives. We sought to determine the use and association with 30-day mortality of intravenous heparin for the treatment of acute myocardial infarction in elderly patients not treated with a reperfusion strategy and without contraindications to anticoagulation.Background. The benefit of using full-dose intravenous heparin for the treatment of acute myocardial infarction in the elderly is not known.Methods. We conducted a retrospective cohort study using hospital medical records of all Medicare beneficiaries admitted to the hospital with an acute myocardial infarction in Alabama, Connecticut, Iowa and Wisconsin from June 1992 through February 1993.Results. Among the 6,935 patients ≥65 years old who had no absolute chart-documented contraindications to heparin, 3,227 (47%) received early full-dose intravenous heparin therapy. After adjustment for baseline differences in demographic, clinical and treatment factors between patients with and without heparin, the use of heparin (odds ratio 1.02, 95% confidence interval 0.87 to 1.18) was not associated with a significantly better 30-day mortality rate.Conclusions. Although intravenous heparin was commonly used for treatment of acute myocardial infarction in the elderly, it was not associated with an improved 30-day mortality rate. Although the findings of this observational study must be interpreted with care, they lead us to question whether the prevalent use of intravenous heparin has therapeutic effectiveness in this population.

BackgroundThe increase in hospitalist-provided inpatient care may be accompanied by an expectation of improvement on patient outcomes. To date, the association between utilization of hospitalists and the publicly reported patient outcomes is unknown.ObjectiveAssess the relationship between hospitalist utilization and performance on 6 publicly reported patient outcomes.DesignCross-sectional study.ParticipantsRepresentatives of 598 hospitals in the United States with direct knowledge of inpatient service models.InterventionSurvey of hospital personnel with knowledge of hospitalist use and hospitalist programs.MeasurementsSix publicly reported quality outcome measures across 3 medical conditions: acute myocardial infarction (AMI), congestive heart failure (HF), and pneumonia. Using multivariable regression models, we assessed the relationship between presence of hospitalists and performance on each outcome measure; we further assessed the relationship between the percentage of patients admitted by hospitalists and each outcome measure.ResultsOf 598 respondents, 429 (72%) reported the use of hospitalist services. In the comparison of hospitals with and without hospitalists, there was no statistically significant difference on any of the mortality or readmissions measures with the exception of the risk-stratified readmission rate for heart failure. For hospitals that used hospitalists, there was no significant change in any of the outcome measures with increasing percentage of patients admitted by hospitalists.ConclusionsThe presence of hospitalists is not an independent predictor of performance on publicly reported mortality and readmissions measures for AMI, HF, or pneumonia. It is likely that broader system or organizational interventions are required to improve performance on patient outcomes.

ObjectivesThis study sought to determine the range and prevalence of practices being implemented by hospitals to reduce 30-day readmissions of patients with heart failure or acute myocardial infarction (AMI).BackgroundReadmissions of patients with heart failure or AMI are both common and costly; however, evidence on strategies adopted by hospitals to reduce readmission rates is limited.MethodsWe used a Web-based survey to conduct a cross-sectional study of hospitals' reported use of specific practices to reduce readmissions for patients with heart failure or AMI. We contacted all hospitals enrolled in the Hospital to Home (H2H) quality improvement initiative as of July 2010. Of 594 hospitals, 537 completed the survey (response rate of 90.4%). We used standard frequency analysis to describe the prevalence of key hospital practices in the areas of: 1) quality improvement resources and performance monitoring; 2) medication management efforts; and 3) discharge and follow-up processes.ResultsNearly 90% of hospitals agreed or strongly agreed that they had a written objective of reducing preventable readmission for patients with heart failure or AMI. More hospitals reported having quality improvement teams to reduce preventable readmissions for patients with heart failure (87%) than for patients with AMI (54%). Less than one-half (49.3%) of hospitals had partnered with community physicians and only 23.5% had partnered with local hospitals to manage patients at high risk for readmissions. Inpatient and outpatient prescription records were electronically linked usually or always in 28.9% of hospitals, and the discharge summary was always sent directly to the patient's primary medical doctor in only 25.5% of hospitals. On average, hospitals used 4.8 of 10 key practices

The purpose of this study was to describe radiation exposure from cardiac imaging procedures over time in a general population.Cardiac imaging procedures frequently expose patients to ionizing radiation, but their contribution to effective doses of radiation in the general population is unknown.We used administrative claims to identify cardiac imaging procedures performed from 2005 to 2007 in 952,420 nonelderly insured adults in 5 U.S. health care markets. We estimated 3-year cumulative effective doses of radiation in millisieverts from these procedures We then calculated population-based annual rates of radiation exposure to effective dosesor =3 mSv/year (background level of radiation from natural sources),3 to 20 mSv/year, or20 mSv/year (upper annual limit for occupational exposure averaged over 5 years).A total of 90,121 (9.5%) individuals underwent at least 1 cardiac imaging procedure using radiation. Among patients who underwentor =1 cardiac imaging procedures, the mean cumulative effective dose over 3 years was 23.1 mSv (range 1.5 to 543.7 mSv). Myocardial perfusion imaging accounted for 74% of the cumulative effective dose. Overall, 47.8% of cardiac imaging procedures were performed in physician offices; this proportion was higher for myocardial perfusion imaging (74.8%) and cardiac computed tomography studies (76.5%). The annual population-based rate of receiving an effective dose of3 to 20 mSv/year was 89.0 per 1,000; and 3.3 per 1,000 for cumulative doses20 mSv/year. Annual effective doses increased with age and were generally higher among men.Cardiac imaging procedures lead to substantial radiation exposure and effective doses for many patients in the U.S.

It is important that the medical profession play a central role in critically evaluating the use of diagnostic procedures and therapies introduced and tested for detection, management, or prevention of disease. Rigorous, expert analysis of the available data documenting absolute and relative

Background: Heart failure as recognized and treated in typical practice may represent a complex condition that defies discrete categorizations. To illuminate this complexity, we examined treatment strategies for patients hospitalized and treated for decompensated heart failure. We focused on the receipt of medications appropriate for other acute conditions associated with shortness of breath including acute asthma, pneumonia, and exacerbated chronic obstructive pulmonary disease. Methods and Results: Using Premier Perspective®, we studied adults hospitalized with a principal discharge diagnosis of heart failure and evidence of acute heart failure treatment from 2009-2010 at 370 US hospitals. We determined treatment with acute respiratory therapies during the initial 2 days of hospitalization and daily during hospital days 3-5. We also calculated adjusted odds of in-hospital death, admission to the intensive care unit, and late intubation (intubation after hospital day 2). Among 164,494 heart failure hospitalizations, 53% received acute respiratory therapies during the first 2 hospital days: 37% received short-acting inhaled bronchodilators, 33% received antibiotics, and 10% received high-dose corticosteroids. Of these 87,319 hospitalizations, over 60% continued receiving respiratory therapies after hospital day 2. Respiratory treatment was more frequent among the 60,690 hospitalizations with chronic lung disease. Treatment with acute respiratory therapy during the first 2 hospital days was associated with higher adjusted odds of all adverse outcomes. Conclusions: Acute respiratory therapy is administered to more than half of patients hospitalized with and treated for decompensated heart failure. Heart failure is therefore regularly treated as a broader cardiopulmonary syndrome rather than as a singular cardiac condition.

BACKGROUND: Low-risk limits recommended for alcohol consumption vary substantially across different national guidelines. To define thresholds associated with lowest risk for all-cause mortality and cardiovascular disease, we studied individual-participant data from 599 912 current drinkers without previous cardiovascular disease. METHODS: We did a combined analysis of individual-participant data from three large-scale data sources in 19 high-income countries (the Emerging Risk Factors Collaboration, EPIC-CVD, and the UK Biobank). We characterised dose-response associations and calculated hazard ratios (HRs) per 100 g per week of alcohol (12·5 units per week) across 83 prospective studies, adjusting at least for study or centre, age, sex, smoking, and diabetes. To be eligible for the analysis, participants had to have information recorded about their alcohol consumption amount and status (ie, non-drinker vs current drinker), plus age, sex, history of diabetes and smoking status, at least 1 year of follow-up after baseline, and no baseline history of cardiovascular disease. The main analyses focused on current drinkers, whose baseline alcohol consumption was categorised into eight predefined groups according to the amount in grams consumed per week. We assessed alcohol consumption in relation to all-cause mortality, total cardiovascular disease, and several cardiovascular disease subtypes. We corrected HRs for estimated long-term variability in alcohol consumption using 152 640 serial alcohol assessments obtained some years apart (median interval 5·6 years [5th-95th percentile 1·04-13·5]) from 71 011 participants from 37 studies. FINDINGS: In the 599 912 current drinkers included in the analysis, we recorded 40 310 deaths and 39 018 incident cardiovascular disease events during 5·4 million person-years of follow-up. For all-cause mortality, we recorded a positive and curvilinear association with the level of alcohol consumption, with the minimum mortality risk around or below 100 g per week. Alcohol consumption was roughly linearly associated with a higher risk of stroke (HR per 100 g per week higher consumption 1·14, 95% CI, 1·10-1·17), coronary disease excluding myocardial infarction (1·06, 1·00-1·11), heart failure (1·09, 1·03-1·15), fatal hypertensive disease (1·24, 1·15-1·33); and fatal aortic aneurysm (1·15, 1·03-1·28). By contrast, increased alcohol consumption was log-linearly associated with a lower risk of myocardial infarction (HR 0·94, 0·91-0·97). In comparison to those who reported drinking >0-≤100 g per week, those who reported drinking >100-≤200 g per week, >200-≤350 g per week, or >350 g per week had lower life expectancy at age 40 years of approximately 6 months, 1-2 years, or 4-5 years, respectively. INTERPRETATION: In current drinkers of alcohol in high-income countries, the threshold for lowest risk of all-cause mortality was about 100 g/week. For cardiovascular disease subtypes other than myocardial infarction, there were no clear risk thresholds below which lower alcohol consumption stopped being associated with lower disease risk. These data support limits for alcohol consumption that are lower than those recommended in most current guidelines.

Evidence for the effectiveness and safety of the third-generation beta-blockers other than atenolol in hypertension remains scarce. We assessed the effectiveness and safety of beta-blockers as first-line treatment for hypertension using three databases in the United States: two administrative claim databases and one electronic health record-based database from 2001 to 2018. In each database, comparative effectiveness of beta-blockers for the risks of acute myocardial infarction, stroke, and hospitalization for heart failure was assessed, using large-scale propensity adjustment and empirical calibration. Estimates were combined across databases using random-effects meta-analyses. Overall, 118,133 and 267,891 patients initiated third-generation beta-blockers (carvedilol and nebivolol) or atenolol, respectively. The pooled hazard ratios of acute myocardial infarction, stroke, hospitalization for heart failure, and most metabolic complications were not different between the third-generation beta-blockers versus atenolol after propensity score matching and empirical calibration (hazard ratio 1.07, 95% CI 0.74 to 1.55 for acute myocardial infarction; hazard ratio 1.06, 95% CI 0.87 to 1.31 for stroke; hazard ratio 1.46, 95% CI 0.99 to 2.24 for hospitalized heart failure). Third-generation beta-blockers were associated with significantly higher risk of stroke than angiotensin-converting enzyme inhibitors (hazard ratio 1.29, 95% CI 1.03 to 1.72), and thiazide diuretics (hazard ratio 1.56, 95% CI 1.17 to 2.20). In conclusion, this study found many patients with first-line beta-blocker monotherapy for hypertension and no statistically significant differences in the effectiveness and safety comparing atenolol with third-generation beta-blockers. Patients on third-generation beta-blockers had a higher risk of stroke than those on angiotensin-converting enzyme inhibitors and thiazide diuretics.

Importance Chlorthalidone is currently recommended as the preferred thiazide diuretic to treat hypertension, but no trials have directly compared risks and benefits. Objective To compare the effectiveness and safety of chlorthalidone and hydrochlorothiazide as first-line therapies for hypertension in real-world practice. Design, Setting, and Participants This is a Large-Scale Evidence Generation and Evaluation in a Network of Databases (LEGEND) observational comparative cohort study with large-scale propensity score stratification and negative-control and synthetic positive-control calibration on databases spanning January 2001 through December 2018. Outpatient and inpatient care episodes of first-time users of antihypertensive monotherapy in the United States based on 2 administrative claims databases and 1 collection of electronic health records were analyzed. Analysis began June 2018. Exposures Chlorthalidone and hydrochlorothiazide. Main Outcomes and Measures The primary outcomes were acute myocardial infarction, hospitalization for heart failure, ischemic or hemorrhagic stroke, and a composite cardiovascular disease outcome including the first 3 outcomes and sudden cardiac death. Fifty-one safety outcomes were measured. Results Of 730 225 individuals (mean [SD] age, 51.5 [13.3] years; 450 100 women [61.6%]), 36 918 were dispensed or prescribed chlorthalidone and had 149 composite outcome events, and 693 337 were dispensed or prescribed hydrochlorothiazide and had 3089 composite outcome events. No significant difference was found in the associated risk of myocardial infarction, hospitalized heart failure, or stroke, with a calibrated hazard ratio for the composite cardiovascular outcome of 1.00 for chlorthalidone compared with hydrochlorothiazide (95% CI, 0.85-1.17). Chlorthalidone was associated with a significantly higher risk of hypokalemia (hazard ratio [HR], 2.72; 95% CI, 2.38-3.12), hyponatremia (HR, 1.31; 95% CI, 1.16-1.47), acute renal failure (HR, 1.37; 95% CI, 1.15-1.63), chronic kidney disease (HR, 1.24; 95% CI, 1.09-1.42), and type 2 diabetes mellitus (HR, 1.21; 95% CI, 1.12-1.30). Chlorthalidone was associated with a significantly lower risk of diagnosed abnormal weight gain (HR, 0.73; 95% CI, 0.61-0.86). Conclusions and Relevance This study found that chlorthalidone use was not associated with significant cardiovascular benefits when compared with hydrochlorothiazide, while its use was associated with greater risk of renal and electrolyte abnormalities. These findings do not support current recommendations to prefer chlorthalidone vs hydrochlorothiazide for hypertension treatment in first-time users was found. We used advanced methods, sensitivity analyses, and diagnostics, but given the possibility of residual confounding and the limited length of observation periods, further study is warranted.