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Competing Interests: Funding Support and Author Disclosures Dr Lu has received research grants from the U.S. National Institutes of Health, the Patient-Centered Outcomes Research Institute, and the Sentara Research Foundation outside of the submitted work. Dr Caraballo was supported by a grant from the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) (U01FD005938). Dr Khera is an Associate Editor of JAMA; has received support from the National Heart, Lung, and Blood Institute of the National Institutes of Health (under awards R01HL167858 and K23HL153775) and the Doris Duke Charitable Foundation (under award 2022060); has received research support, through Yale, from Bristol Myers Squibb, Novo Nordisk, and BridgeBio; is a coinventor of U.S. Pending Patent Applications 63/562,335, 63/177,117, 63/428,569, 63/346,610, 63/484,426, 63/508,315, and 63/606,203; and is a cofounder of Ensight-AI Inc and Evidence2Health, health platforms to improve cardiovascular diagnosis and evidence-based cardiovascular care. Dr Krumholz has received options for Element Science and Identifeye and payments from F-Prime for advisory roles (in the past 3 years); is a cofounder of and holds equity in Hugo Health, Refactor Health, and Ensight-AI; and is associated with research contracts through Yale University from Johnson and Johnson, Kenvue, Novartis, and Pfizer. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Balancing the safety and efficacy of antithrombotic agents in patients with gastrointestinal disorders is challenging because of the potential for interference with the absorption of antithrombotic drugs and for an increased risk of bleeding. In this Review, we address considerations for enteral antithrombotic therapy in patients with cardiovascular disease and gastrointestinal comorbidities. For those with gastrointestinal bleeding (GIB), we summarize a general scheme for risk stratification and clinical evidence on risk reduction approaches, such as limiting the use of concomitant medications that increase the risk of GIB and the potential utility of gastrointestinal protection strategies (such as proton pump inhibitors or histamine type 2 receptor antagonists). Furthermore, we summarize the best available evidence and potential gaps in our knowledge on tailoring antithrombotic therapy in patients with active or recent GIB and in those at high risk of GIB but without active or recent GIB. Finally, we review the recommendations provided by major medical societies, highlighting the crucial role of teamwork and multidisciplinary discussions to customize the antithrombotic regimen in patients with coexisting cardiovascular and gastrointestinal diseases., (© 2024. Springer Nature Limited.)

Background: Quasi-experimental methods (QEMs) are a family of techniques used to estimate causal relationships when randomized controlled trials are unfeasible or unethical. They offer a powerful alternative to observational studies by introducing random assignment of individuals or groups into their design, thereby offering stronger means of establishing causation. The use of QEMs in cardiovascular research has not been systematically examined to determine steps toward improving and expanding their use., Methods: We identified 4 main techniques using a systematic search strategy from 2016 to 2021: instrumental variable analysis, interrupted time series analysis, difference-in-differences analysis, and regression discontinuity designs. QEMs are examined as alternatives to randomized controlled trials and traditional observational studies; as more observational data becomes available to researchers, there are more opportunities to apply these techniques. Eligible articles were selected based on publication in high-ranked journals. The quality of eligible articles was appraised using the Joanna Briggs Institute checklist for quasi-experimental studies., Results: Data from 380 studies were extracted based on our inclusion criteria. Forty-two of these studies were published in the top 10 medical or top 20 cardiovascular disease journals, and 25 studies were included after quality appraisal. The review identifies the main features and limitations associated with each technique, providing readers with practical guidance on how to apply these to their research. A graphical decision aid was developed to facilitate the routine use of QEMs., Conclusions: The use of QEMs in cardiovascular research published in contemporary, high-impact articles was examined. Findings are biased toward this segment of literature, which represents the latest developments in this growing area of cardiovascular research. The decision aid is a novel schematic that researchers can adopt into practice., Competing Interests: Disclosures None.

Competing Interests: Disclosures Drs Lu and Krumholz had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Dr Jastreboff conducts multicenter trials with Eli Lilly, Novo Nordisk, and Rhythm Pharmaceuticals; serves on scientific advisory boards for Amgen, AstraZeneca, Boehringer Ingelheim, Biohaven, Eli Lilly, Intellihealth, Novo Nordisk, Pfizer, Rhythm Pharmaceuticals, Scholar Rock, Structure Therapeutics, Terms Pharmaceutical, WeightWatchers, and Zealand Pharmaceuticals; was the site principal investigator for the SELECT (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity) trial at Yale University; and receives institutional grant funding from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Dr Rodriguez reports consulting relationships with Healthpals, Novartis, Esperion, NovoNordisk (Clinical Events Committee), Movano Health, and Kento Health. In the past three years, Harlan Krumholz received expenses or personal fees from Element Science, Eyedentify, and F-Prime. He is a co-founder of Hugo Health, Refactor Health, and Ensight-AI. He is the co-editor of Journal Watch: Cardiology of the Massachusetts Medical Society and is a section editor of UpToDate. He is associated with contracts, through Yale New Haven Hospital, from the Centers for Medicare & Medicaid Services and through Yale University from Janssen, Johnson & Johnson Consumer, and Pfizer. Dr. Lu received support from the Sentara Research Foundation, the National Heart, Lung, and Blood Institute of the National Institutes of Health (under awards R01HL69954 and R01HL169171), and the Patient-Centered Outcomes Research Institute (under award HM-2022C2-28354). Dr. Khera is an Associate Editor of JAMA. He receives support from the National Heart, Lung, and Blood Institute of the National Institutes of Health (under award K23HL153775) and the Doris Duke Charitable Foundation (under award 2022060). He also receives research support, through Yale, from Bristol-Myers Squibb and Novo Nordisk. He is a coinventor of U.S. Provisional Patent Applications 63/177,117, 63/428,569, 63/346,610, 63/484,426, and 63/508,315. He is a co-founder of Ensight-AI and Evidence2Health, health platforms to improve cardiovascular diagnosis and evidence-based cardiovascular care. All data used in this study are publicly available at https://www.cdc.gov/nchs/nhanes/index.htm. The other authors report no conflicts.

Importance: Despite efforts to improve the quality of care for patients with atherosclerotic cardiovascular disease (ASCVD), it is unclear whether the US has made progress in reducing racial and ethnic differences in utilization of guideline-recommended therapies for secondary prevention., Objective: To evaluate 21-year trends in racial and ethnic differences in utilization of guideline-recommended pharmacological medications and lifestyle modifications among US adults with ASCVD., Design, Setting, and Participants: This cross-sectional study includes data from the National Health and Nutrition Examination Survey between 1999 and 2020. Eligible participants were adults aged 18 years or older with a history of ASCVD. Data were analyzed between March 2022 and May 2023., Exposure: Self-reported race and ethnicity., Main Outcome and Measures: Rates and racial and ethnic differences in the use of guideline-recommended pharmacological medications and lifestyle modifications., Results: The study included 5218 adults with a history of ASCVD (mean [SD] age, 65.5 [13.2] years, 2148 women [weighted average, 44.2%]), among whom 1170 (11.6%) were Black, 930 (7.7%) were Hispanic or Latino, and 3118 (80.7%) were White in the weighted sample. Between 1999 and 2020, there was a significant increase in total cholesterol control and statin use in all racial and ethnic subgroups, and in angiotensin-converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) utilization in non-Hispanic White individuals and Hispanic and Latino individuals (Hispanic and Latino individuals: 17.12 percentage points; 95% CI, 0.37-37.88 percentage points; P = .046; non-Hispanic White individuals: 12.14 percentage points; 95% CI, 6.08-18.20 percentage points; P < .001), as well as smoking cessation within the Hispanic and Latino population (-27.13 percentage points; 95% CI, -43.14 to -11.12 percentage points; P = .002). During the same period, the difference in smoking cessation between Hispanic and Latino individuals and White individuals was reduced (-24.85 percentage points; 95% CI, -38.19 to -11.51 percentage points; P < .001), but racial and ethnic differences for other metrics did not change significantly. Notably, substantial gaps persisted between current care and optimal care throughout the 2 decades of data analyzed. In the period of 2017 to 2020, optimal regimens were observed in 47.4% (95% CI, 39.3%-55.4%), 48.7% (95% CI, 36.7%-60.6%), and 53.0% (95% CI, 45.6%-60.4%) of Black, Hispanic and Latino, and White individuals, respectively., Conclusions and Relevance: In this cross-sectional study of US adults with ASCVD, significant disparities persisted between current care and optimal care, surpassing any differences observed among demographic groups. These findings highlight the critical need for sustained efforts to bridge these gaps and achieve better outcomes for all patients, regardless of their racial and ethnic backgrounds.

Average ambient fine particulate matter (PM 2.5 ) concentrations have decreased in the US in recent years, but the health benefits of this improvement among different racial/ethnic groups are unknown. We estimate the associations between long-term exposure to ambient PM 2.5 and cause-specific cardiovascular disease (CVD) mortality rate and assess the PM 2.5 -attributable CVD deaths by race/ethnicity across 3,103 US counties during 2001-2016 (n = 595,776 county-months). A 1 µg m - 3 increase in PM 2.5 concentration was associated with increases of 7.16 (95% confidence interval (CI): 3.81, 10.51) CVD deaths per 1,000,000 Black people per month, significantly higher than the estimates for non-Hispanic white people (1.76 (95% CI: 1.37, 2.15); difference in coefficients: 5.40 (95% CI: 2.03, 8.77), P = 0.001). No significant difference in this association was observed between Hispanic (2.66 (95% CI: -0.03, 5.35)) and non-Hispanic white people (difference in coefficients: 0.90 (95% CI: -1.81, 3.61), P = 0.523). From 2001 to 2016, the absolute disparity in PM 2.5 -attributable CVD mortality burden was reduced by 44.04% between non-Hispanic Black and white people and by 2.61% between Hispanic and non-Hispanic white people. However, in 2016, the burden remained 3.47 times higher for non-Hispanic Black people and 0.45 times higher for Hispanic people than for non-Hispanic white people. We call for policies that aim to reduce both exposure and vulnerability to PM 2.5 for racial/ethnic minorities., (© 2023. The Author(s), under exclusive licence to Springer Nature Limited.)

Importance: Wearable devices may be able to improve cardiovascular health, but the current adoption of these devices could be skewed in ways that could exacerbate disparities., Objective: To assess sociodemographic patterns of use of wearable devices among adults with or at risk for cardiovascular disease (CVD) in the US population in 2019 to 2020., Design, Setting, and Participants: This population-based cross-sectional study included a nationally representative sample of the US adults from the Health Information National Trends Survey (HINTS). Data were analyzed from June 1 to November 15, 2022., Exposures: Self-reported CVD (history of heart attack, angina, or congestive heart failure) and CVD risk factors (≥1 risk factor among hypertension, diabetes, obesity, or cigarette smoking)., Main Outcomes and Measures: Self-reported access to wearable devices, frequency of use, and willingness to share health data with clinicians (referred to as health care providers in the survey)., Results: Of the overall 9303 HINTS participants representing 247.3 million US adults (mean [SD] age, 48.8 [17.9] years; 51% [95% CI, 49%-53%] women), 933 (10.0%) representing 20.3 million US adults had CVD (mean [SD] age, 62.2 [17.0] years; 43% [95% CI, 37%-49%] women), and 5185 (55.7%) representing 134.9 million US adults were at risk for CVD (mean [SD] age, 51.4 [16.9] years; 43% [95% CI, 37%-49%] women). In nationally weighted assessments, an estimated 3.6 million US adults with CVD (18% [95% CI, 14%-23%]) and 34.5 million at risk for CVD (26% [95% CI, 24%-28%]) used wearable devices compared with an estimated 29% (95% CI, 27%-30%) of the overall US adult population. After accounting for differences in demographic characteristics, cardiovascular risk factor profile, and socioeconomic features, older age (odds ratio [OR], 0.35 [95% CI, 0.26-0.48]), lower educational attainment (OR, 0.35 [95% CI, 0.24-0.52]), and lower household income (OR, 0.42 [95% CI, 0.29-0.60]) were independently associated with lower use of wearable devices in US adults at risk for CVD. Among wearable device users, a smaller proportion of adults with CVD reported using wearable devices every day (38% [95% CI, 26%-50%]) compared with overall (49% [95% CI, 45%-53%]) and at-risk (48% [95% CI, 43%-53%]) populations. Among wearable device users, an estimated 83% (95% CI, 70%-92%) of US adults with CVD and 81% (95% CI, 76%-85%) at risk for CVD favored sharing wearable device data with their clinicians to improve care., Conclusions and Relevance: Among individuals with or at risk for CVD, fewer than 1 in 4 use wearable devices, with only half of those reporting consistent daily use. As wearable devices emerge as tools that can improve cardiovascular health, the current use patterns could exacerbate disparities unless there are strategies to ensure equitable adoption.

Despite considerable progress in tackling cardiovascular disease over the past 50 years, many gaps in the quality of care for cardiovascular disease remain. Multiple missed opportunities have been identified at every step in the prevention and treatment of cardiovascular disease, such as failure to make risk factor modifications, failure to diagnose cardiovascular disease, and failure to use proper evidence based treatments. With the digital transformation of medicine and advances in health information technology, clinical decision support (CDS) tools offer promise to enhance the efficiency and effectiveness of delivery of cardiovascular care. However, to date, the promise of CDS delivering scalable and sustained value for patient care in clinical practice has not been realized. This article reviews the evidence on key emerging questions around the development, implementation, and regulation of CDS with a focus on cardiovascular disease. It first reviews evidence on the effectiveness of CDS on healthcare process and clinical outcomes related to cardiovascular disease and design features associated with CDS effectiveness. It then reviews the barriers encountered during implementation of CDS in cardiovascular care, with a focus on unintended consequences and strategies to promote successful implementation. Finally, it reviews the legal and regulatory environment of CDS with specific examples for cardiovascular disease., Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and declare the following interests: HMK has received personal fees from UnitedHealth, Element Science, Aetna, Reality Labs, F-Prime, Siegfried & Jensen Law Firm, Martin/Baughman Law Firm, and Arnold and Porter Law Firm and grants from Johnson & Johnson; he is a co-founder of HugoHealth, a personal health information platform, and co-founder of Refactor Health, an enterprise healthcare artificial intelligence-augmented data management company, and he has contracts from Centers for Medicare & Medicaid Services Contracts, through Yale New Haven Hospital, to develop and maintain performance measures that are publicly reported outside the submitted work; YL is supported in part by the National Heart, Lung, and Blood Institute (K12HL138037) and the Yale Center for Implementation Science; ERM is supported in part by the National Institute On Drug Abuse of the National Institutes of Health under Award Number UH3DA047003. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: People who have been incarcerated have high rates of cardiovascular risk factors, such as hypertension and smoking, and cardiovascular disease (CVD) is a leading cause of hospitalizations and mortality in this population. Despite this, little is known regarding what pathways mediate the association between incarceration exposure and increased rates of CVD morbidity and especially what incarceration specific factors are associated with this risk. The objective of this study is to better understand CVD risk in people exposed to incarceration and the pathways by which accumulate cardiovascular risk over time., Methods and Analysis: The Justice-Involved Individuals Cardiovascular Disease Epidemiology (JUSTICE) study is a prospective cohort study of individuals released from incarceration with known cardiovascular risk factors. We are recruiting 500 individuals within three months after release from jail/prison. At baseline we are assessing traditional risk factors for CVD, including diet, exercise, and smoking, and exposure to incarceration-related policies, psychosocial stress, and self-efficacy. Cardiovascular risk factors are measured at baseline through point of care testing. We are following these individuals for the 12 months following the index release from incarceration with re-evaluation of psychosocial factors and clinical risk factors every 6 months. Using these data, we will estimate the direct and indirect latent effects of incarceration on cardiovascular risk factors and the paths via which these effects are mediated. We will also model the anticipated 10-year burden of CVD incidence, health care use, and mortality associated with incarceration., Discussion: Our study will identify factors associated with CVD risk factor control among people released from incarceration. Our measurement of incarceration-related exposures, psychosocial factors, and clinical measures of cardiovascular risk will allow for identification of unique targets for intervention to modify CVD risk in this vulnerable population., (© 2022. The Author(s).)

Background/aims: Non-inferiority trials are increasing in cardiovascular medicine, with approval of many drugs and devices on the basis of such studies. Surrogate markers as primary endpoints have been also more frequently used for efficient assessment of cardiovascular interventions. However, there is uncertainty about their concordance with clinical outcomes. Non-inferiority design using a surrogate marker as a primary endpoint may pose particular challenges in clinical interpretation. We sought to explore the publication trends, methodology, and reporting features of non-inferiority cardiovascular trials that used a primary surrogate marker as the primary endpoint., Methods: We searched six high-impact journals ( The New England Journal of Medicine, The Journal of the American Medical Association, The Lancet, The Journal of the American College of Cardiology, Circulation , and European Heart Journal ) from 1 January 1990 to 31 December 2018 and identified non-inferiority cardiovascular trials that used a surrogate marker as the primary endpoint. We assessed the non-inferiority margin reported in the manuscript and other publicly available platforms (e.g. protocol, clinicaltrials.gov). We also determined whether the included non-inferiority trials with surrogate markers as primary endpoints were followed by clinical outcome trials., Results: We screened 15,553 publications and identified 247 cardiovascular trials that used a non-inferiority design. Of these, 37 had a surrogate marker as a primary endpoint (18 drug trials, 13 device trials, 6 others). All of these non-inferiority trials with surrogate outcomes were published after 2000, mostly in cardiology journals (13 in The Journal of the American College of Cardiology , 9 in European Heart Journal , 8 in Circulation , 6 in The Lancet , 1 in The New England Journal of Medicine ), and their publication rate increased over time (p < 0.001 for linear trend). The median number of patients in the primary analysis was 300 (interquartile range: 202-465). The study protocol or a methods paper was publicly available for only 13 (35.1%) trials, of which the non-inferiority margin was not reported in 4 trials. In 16 studies (43.2%), the manuscript did not acknowledge the limitations of using a surrogate endpoint or the need for a definitive clinical outcome trial. Thirty-four trials (91.9%) concluded that the tested intervention met non-inferiority criteria. However, only five (13.5%) were followed by clinical outcomes trials the results of which did not always confirm non-inferiority., Conclusion: Non-inferiority trials that use a surrogate marker as the primary endpoint are being increasingly performed. However, these trials pose particular challenges with design, reporting, and interpretation, which are not systematically and consistently addressed or reported.

Competing Interests: Author Relationship With Industry Dr. Vaduganathan is supported by the KL2/Catalyst Medical Research Investigator Training award from Harvard Catalyst (NIH/NCATS Award UL 1TR002541); has received research support from Amgen; has served on Advisory Boards for Amgen, AstraZeneca, Baxter Healthcare, Bayer AG, Boehringer Ingelheim, Cytokinetics, and Relypsa; and has participated on clinical endpoint committees for studies sponsored by Galmed, Novartis, and the National Institutes of Health. Dr. Butler has served as a consultant to Abbott, Adrenomed, Amgen, Applied Therapeutics, Array, AstraZeneca, Bayer, BerlinCures, Boehringer Ingelheim, Cardior, CVRx, Foundry, G3 Pharma, Imbria, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, NovoNordisk, Relypsa, Roche, Sanofi, Sequana Medical, V-Wave Limited, and Vifor. Dr. Krumholz has received expenses and/or personal fees from UnitedHealth, IBM Watson Health, Element Science, Aetna, Facebook, the Siegfried and Jensen Law Firm, Arnold and Porter Law Firm, Martin/Baughman Law Firm, F-Prime, and the National Center for Cardiovascular Diseases in Beijing; is an owner of Refactor Health and HugoHealth; and has had grants and/or contracts from the Centers for Medicare & Medicaid Services, Medtronic, the U.S. Food and Drug Administration, Johnson & Johnson, and the Shenzhen Center for Health Information. Dr. Bhatt has served on the Advisory Boards of Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, Level Ex, Medscape Cardiology, PhaseBio, PLx Pharma, and Regado Biosciences; has served on the boards of directors of the Boston VA Research Institute, Society of Cardiovascular Patient Care, and TobeSoft; has served as chair of the American Heart Association Quality Oversight Committee; has served on data monitoring committees for the Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial, funded by Edwards Lifesciences), Contego Medical (chair of the PERFORMANCE 2 trial), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi-Sankyo), and Population Health Research Institute; has received honoraria from the American College of Cardiology (senior associate editor, Clinical Trials and News, ACC.org; and vice chair of the ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor-in-Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor-in-Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (guest editor; associate editor), K2P (co-chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (chief medical editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (secretary/treasurer), and WebMD (CME steering committees); has other relationships with Clinical Cardiology (deputy editor), NCDR-ACTION Registry Steering Committee (chair), and VA CART Research and Publications Committee (chair); has received research funding from Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cardax, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lexicon, Lilly, Medtronic, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, Sanofi, Synaptic, and The Medicines Company; has received royalties from Elsevier (editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); has been a site coinvestigator for Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), and Svelte; has been a trustee for the American College of Cardiology; and has performed unfunded research for FlowCo, Merck, Novo Nordisk, and Takeda. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Objective: We aimed to estimate the current use of secondary prevention drugs and identify its associated individual characteristics among those with established cardiovascular diseases (CVDs) in the communities of China., Methods: We studied 2 613 035 participants aged 35-75 years from 8577 communities in 31 provinces in the China Patient-Centered Evaluative Assessment of Cardiac Events Million Persons Project, a government-funded public health programme conducted from 2014 to 2018. Participants self-reported their history of ischaemic heart disease (IHD) or ischaemic stroke (IS) and medication use in an interview. Multivariable mixed models with a logit link function and community-specific random intercepts were fitted to assess the associations of individual characteristics with the reported use of secondary prevention therapies., Results: Among 2 613 035 participants, 2.9% (74 830) reported a history of IHD and/or IS, among whom the reported use rate either antiplatelet drugs or statins was 34.2% (31.5% antiplatelet drugs, 11.0% statins and 8.3% both). Among the 1 530 408 population subgroups, which were defined by all possible permutations of 16 individual characteristics, reported use of secondary prevention drugs varied substantially (8.4%-60.6%). In the multivariable analysis, younger people, women, current smokers, current drinkers, people without hypertension or diabetes and those with established CVD for more than 2 years were less likely to report taking antiplatelet drugs or statins., Conclusions: The current use of secondary prevention drugs in China is suboptimal and varies substantially across population subgroups. Our study identifies target populations for scalable, tailored interventions to improve secondary prevention of CVD., Competing Interests: Competing interests: HK discloses that he is a recipient of research agreements from Medtronic and from Johnson & Johnson (Janssen), through Yale, to develop methods of clinical trial data sharing; is the recipient of a grant from the Food and Drug Administration and Medtronic, through Yale, to develop methods for postmarket surveillance of medical devices; works under contract with the Centers for Medicare & Medicaid Services to develop and maintain performance measures; chairs a cardiac scientific advisory board for UnitedHealth; is a participant/participant representative of the IBM Watson Health Life Sciences Board; is a member of the Advisory Board for Element Science and the Physician Advisory Board for Aetna; and is the founder of Hugo, a personal health information platform. FAM has a contract with the American College of Cardiology for his role as the Chief Scientific Advisor of the NCDR. All other authors declare no competing interests., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Although increased age is associated with higher systolic blood pressure (SBP) in general, there may be variation across individuals in how SBP changes over time. The goal of this paper is to identify heterogeneity in SBP trajectories among young adults with similar initial values and identify personal characteristics associated with different trajectory patterns. This may have important implications for prevention and prognosis., Methods: A cohort of 12,468 individuals aged 18-35 years in the Qingdao Port Cardiovascular Health Study in China was followed yearly during 2000-2011. Individuals were categorized into three strata according to their baseline SBP: ≤110 mmHg, 111-130 mmHg, and >130 mmHg. Within each stratum, group-based trajectory analyses were conducted to identify distinct SBP trajectory patterns, and their association with sociodemographic and baseline health characteristics was assessed by ordinal logistic regression., Results: Five distinct groups of individuals exhibiting divergent patterns of increasing, stable or decreasing SBP trends were identified within each stratum. This is a first report to identify a subgroup with decreasing trend in SBP. Individuals with more advanced age, having less than high school education, family history of cardiovascular diseases, greater body mass index, greater waist circumference, and hyperlipidemia at baseline were more likely to experience trajectories of higher SBP within each stratum., Conclusions: The diverging trajectories among young adults with similar initial SBP highlight the need for prevention and feasibility of effective blood pressure control, while the identified risk factors may inform targeted interventions., Competing Interests: The authors have no competing interests to declare., (Copyright: © 2020 The Author(s).)

Background Observational studies demonstrate that communities of low socioeconomic status have higher blood pressure and worse cardiovascular outcomes. Yet, whether the clinical outcomes resulting from antihypertensive therapy vary by socioeconomic context in a randomized clinical trial, in which participants are treated under a standard protocol, is unknown. Methods and Results We used data from ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) to study the effect of socioeconomic context, defined as the county-level median household income, of study sites. We stratified sites into income quintiles and compared characteristics, blood pressure control, and cardiovascular outcomes among ALLHAT participants in the lowest- and highest-income quintiles. Among 27 862 qualifying participants, 2169 (7.8%) received care in the lowest-income sites (quintile 1) and 10 458 (37.6%) received care in the highest-income sites (quintile 5). Participants in quintile 1 were more likely to be women, to be black, to be Hispanic, to have fewer years of education, to live in the South, and to have fewer cardiovascular risk factors. After adjusting for baseline demographic and clinical characteristics, quintile 1 participants were less likely to achieve blood pressure control (<140/90 mm Hg) (odds ratio, 0.48; 95% CI, 0.37-0.63) and had greater all-cause mortality (hazard ratio [HR], 1.25; 95% CI, 1.10-1.41), heart failure hospitalizations/mortality (HR, 1.26; 95% CI, 1.03-1.55), and end-stage renal disease (HR, 1.86; 95% CI, 1.26-2.73), but lower angina hospitalizations (HR, 0.70; 95% CI, 0.59-0.83) and coronary revascularizations (HR, 0.71; 95% CI, 0.57-0.89). Conclusions Despite standardized treatment protocols, ALLHAT participants in the lowest-income sites experienced poorer blood pressure control and worse outcomes for some adverse cardiovascular events, emphasizing the importance of measuring and addressing socioeconomic context. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00000542.

Background: Noninferiority trials are increasingly being performed. However, little is known about their methodological quality. We sought to characterize noninferiority cardiovascular trials published in the highest-impact journals, features that may bias results toward noninferiority, features related to reporting of noninferiority trials, and the time trends., Methods: We identified cardiovascular noninferiority trials published in JAMA, Lancet, or New England Journal of Medicine from 1990 to 2016. Two independent reviewers extracted the data. Data elements included the noninferiority margin and the success of studies in achieving noninferiority. The proportion of trials showing major or minor features that may have affected the noninferiority inference was determined. Major factors included the lack of presenting the results in both intention-to-treat and per-protocol/as-treated cohorts, α>0.05, the new intervention not being compared with the best alternative, not justifying the noninferiority margin, and exclusion or loss of ≥10% of the cohort. Minor factors included suboptimal blinding, allocation concealment, and others., Results: From 2544 screened studies, we identified 111 noninferiority cardiovascular trials. Noninferiority margins varied widely: risk differences of 0.4% to 25%, hazard ratios of 1.05 to 2.85, odds ratios of 1.1 to 2.0, and relative risks of 1.1 to 1.8. Eighty-six trials claimed noninferiority, of which 20 showed superiority, whereas 23 (21.1%) did not show noninferiority, of which 8 also demonstrated inferiority. Only 7 (6.3%) trials were considered low risk for all the major and minor biasing factors. Among common major factors for bias, 41 (37%) did not confirm the findings in both intention-to-treat and per-protocol/as-treated cohorts and 4 (3.6%) reported discrepant results between intention-to-treat and per-protocol analyses. Forty-three (38.7%) did not justify the noninferiority margin. Overall, 27 (24.3%) underenrolled or had >10% exclusions. Sixty trials (54.0%) were open label. Allocation concealment was not maintained or unclear in 11 (9.9%). Publication of noninferiority trials increased over time (P<0.001). Fifty-two (46.8%) were published after 2010 and had a lower risk of methodological or reporting limitations for major (P=0.03) and minor factors (P=0.002)., Conclusions: Noninferiority trials in highest-impact journals commonly conclude noninferiority of the tested intervention, but vary markedly in the selected noninferiority margin, and frequently have limitations that may impact the inference related to noninferiority.

Background: As cardiovascular risk increases in China, interest in strategies to mitigate it is growing. However, national information about the prevalence and treatment of high cardiovascular disease (CVD) risk is limited., Objective: To assess the prevalence and treatment of high CVD risk as well as variations in risk across population subgroups., Design: National project of CVD screening and management., Setting: 141 county-level regions in all 31 provinces of China., Participants: Local residents aged 35 to 75 years., Measurements: Rates of high CVD risk were assessed both in the overall study population and by age, sex, body mass index, geographic region, and socioeconomic status. Multivariable mixed models were fitted to assess the associations between individual characteristics and high CVD risk. Statin and aspirin use was evaluated among persons at high risk for CVD., Results: Among 1 680 126 participants, 9.5% (95% CI, 9.5% to 9.6%) had high risk for CVD. Mixed models identified persons who were of Han ethnicity, had medical insurance, were currently using alcohol, or were obese as more likely to be at high risk for CVD. Of those with high CVD risk, only 0.6% (CI, 0.5% to 0.6%) and 2.4% (CI, 2.3% to 2.5%) reported using statins and aspirin, respectively. Among persons with high CVD risk and hypertension, 31.8% were receiving antihypertensive medications., Limitation: Samples were not nationally representative., Conclusion: Of the 1.7 million participants, 1 in 10 had a high risk for CVD; among those at high risk, fewer than 3% were receiving statins or aspirin. An immense opportunity exists for risk mitigation in this substantial population., Primary Funding Source: Ministry of Finance and National Health Commission, China.

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 Author(s) 2018. Published by Oxford University Press on behalf of the European Society of Cardiology.)

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.

Objectives: To understand the discrepancy between the published 10-year cardiovascular risk and 10-year cardiovascular risk generated from raw data using the Framingham Risk Score for participants in the Systolic Blood Pressure Intervention Trial (SPRINT)., Design: Secondary analysis of SPRINT data published in The New England Journal of Medicine ( NEJM ) and made available to researchers in late 2016., Setting: SPRINT clinical trial sites., Participants: Study participants enrolled into SPRINT., Results: The number of SPRINT study participants identified as having ≥15% 10-year cardiovascular risk was not consistent with what was reported in the original publication. Using the data from the trial, the Framingham Risk Score indicated ≥15% 10-year cardiovascular risk for 7089 participants compared with 5737 reported in the paper, a change from 61% to 76% of the total study population., Conclusions: The analysis of the clinical trial data by independent investigators identified an error in the reporting of the risk of the study population. The SPRINT trial enrolled a higher risk population than was reported in the initial publication, which was brought to light by data sharing., Competing Interests: Competing interests: Drs HMK and JSR are recipients of research agreements from Medtronic and Johnson & Johnson (Janssen), through Yale, to develop methods of clinical trial data sharing and of a grant from Medtronic and the Food and Drug Administration, through Yale, to develop methods for postmarket surveillance of medical devices and work under contract with the Centers for Medicare and Medicaid Services to develop and maintain performance measures that are publicly reported. Dr HMK chairs a cardiac scientific advisory board for United Health, is a participant/participant representative of the IBM Watson Health Life Sciences Board, is a member of the Advisory Board for Element Science and the Physician Advisory Board for Aetna and is the founder of Hugo, a personal health information platform. Dr JSR has received research support from the Blue Cross Blue Shield Association to better understand medical technology evidence generation. The other co-authors report no potential competing interests., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

With the advent of international precision medicine initiatives, it is important to evaluate existing large-scale studies to inform future investigation. This study sought to review, describe, and evaluate all large-scale cardiovascular disease (CVD) studies completed in China. We undertook a review of all large-scale CVD studies completed in China to describe and evaluate their design, implementation, and dissemination in published medical reports. Seventeen studies met the inclusion criteria. There were substantial variations in study design, geographic location, and data collection. Most studies lacked standard study names, did not publish their methods, and provided no publicly available data. Few studies included underdeveloped regions or minority groups. Most published articles contained only descriptions of the average population at risk of CVD, and no study predicted individual CVD risk or identified people at high risk. Future CVD studies in China may need to incorporate stronger systematic data collection methods, increased data transparency, clearer documentation, and standard study names to most gain from China's burgeoning field of CVD research., (Copyright © 2017 World Heart Federation (Geneva). Published by Elsevier B.V. All rights reserved.)

Background: The reasons for China's 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 China's 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., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Importance: Preliminary cost-effectiveness analyses of proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) were based on benefits estimated from reductions in low-density lipoprotein cholesterol that occurred in PCSK9i trials with variable results. The recent Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) trial provides better information about the effectiveness of the drug., Objective: To use the trial results to determine the cost-effectiveness of a PCSK9i and statin treatment strategy compared with a statin alone strategy., Design, Setting, and Participants: We derived observed rates of events, outcomes, cost of care, and health insurance from existing literature for a theoretical cohort of patients designed to resemble the FOURIER PCSK9i trial population and created a Markov model during the time horizon of a full lifetime., Main Outcomes and Measures: We evaluated the incremental cost-effectiveness ratio from a health system perspective, and the return on investment from a private payer perspective. For both measures, we assumed an annual PCSK9i drug price of $14 300, with a lapse in US patent protection that would reduce the price by 43% in year 12. Costs were reported in 2016 US dollars., Results: This study modeled 1000 hypothetical patients with attributes similar to those of the FOURIER trial cohort. At the current price, the incremental cost-effectiveness ratio of statin plus PCSK9i therapy was $337 729 per quality-adjusted life-year. Our probabilistic sensitivity analysis found that a statin plus PCSK9i strategy had a low probability (<1%) of being cost effective at the commonly accepted societal threshold of $100 000 per quality-adjusted life-year. Furthermore, PCSK9i produced a negative return on investment of 86% for private payers. In our threshold analysis, the price of PCSK9i would need to drop 62%, to $5459 per year, to reach $100 000 per quality-adjusted life year., Conclusions and Relevance: At current prices, the addition of PCSK9i to statin therapy is estimated to provide an additional quality-adjusted life year for $337 729 . Significant discounts are necessary to meet conventional cost-effectiveness standards.

Randomized trials of hypertension have seldom examined heterogeneity in response to treatments over time and the implications for cardiovascular outcomes. Understanding this heterogeneity, however, is a necessary step toward personalizing antihypertensive therapy. We applied trajectory-based modeling to data on 39 763 study participants of the ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) to identify distinct patterns of systolic blood pressure (SBP) response to randomized medications during the first 6 months of the trial. Two trajectory patterns were identified: immediate responders (85.5%), on average, had a decreasing SBP, whereas nonimmediate responders (14.5%), on average, had an initially increasing SBP followed by a decrease. Compared with those randomized to chlorthalidone, participants randomized to amlodipine (odds ratio, 1.20; 95% confidence interval [CI], 1.10-1.31), lisinopril (odds ratio, 1.88; 95% CI, 1.73-2.03), and doxazosin (odds ratio, 1.65; 95% CI, 1.52-1.78) had higher adjusted odds ratios associated with being a nonimmediate responder (versus immediate responder). After multivariable adjustment, nonimmediate responders had a higher hazard ratio of stroke (hazard ratio, 1.49; 95% CI, 1.21-1.84), combined cardiovascular disease (hazard ratio, 1.21; 95% CI, 1.11-1.31), and heart failure (hazard ratio, 1.48; 95% CI, 1.24-1.78) during follow-up between 6 months and 2 years. The SBP response trajectories provided superior discrimination for predicting downstream adverse cardiovascular events than classification based on difference in SBP between the first 2 measurements, SBP at 6 months, and average SBP during the first 6 months. Our findings demonstrate heterogeneity in response to antihypertensive therapies and show that chlorthalidone is associated with more favorable initial response than the other medications., (© 2017 American Heart Association, Inc.)

Background: Surrogate endpoint trials test strategies more efficiently but are accompanied by uncertainty about the relationship between changes in surrogate markers and clinical outcomes., Methods and Results: We identified cardiovascular trials with primary surrogate endpoints published in the New England Journal of Medicine , Lancet , and JAMA: Journal of the American Medical Association from 1990 to 2011 and determined the trends in publication of surrogate endpoint trials and the success of the trials in meeting their primary endpoints. We tracked for publication of clinical outcome trials on the interventions tested in surrogate trials. We screened 3016 articles and identified 220 surrogate endpoint trials. From the total of 220 surrogate trials, 157 (71.4%) were positive for their primary endpoint. Only 59 (26.8%) surrogate trials had a subsequent clinical outcomes trial. Among these 59 trials, 24 outcomes trial results validated the positive surrogates, whereas 20 subsequent outcome trials were negative following positive results on a surrogate. We identified only 3 examples in which the surrogate trial was negative but a subsequent outcomes trial was conducted and showed benefit. Findings were consistent in a sample cohort of 383 screened articles inclusive of 37 surrogate endpoint trials from 6 other high-impact journals., Conclusions: Although cardiovascular surrogate outcomes trials frequently show superiority of the tested intervention, they are infrequently followed by a prominent outcomes trial. When there was a high-profile clinical outcomes study, nearly half of the positive surrogate trials were not validated. Cardiovascular surrogate outcome trials may be more appropriate for excluding benefit from the patient perspective than for identifying it., (© 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Background: In 2008, the National Heart, Lung, and Blood Institute convened an Implementation Science Work Group to assess evidence-based strategies for effectively implementing clinical practice guidelines. This was part of a larger effort to update existing clinical practice guidelines on cholesterol, blood pressure, and overweight/obesity., Objectives: Review evidence from the published implementation science literature and identify effective or promising strategies to enhance the adoption and implementation of clinical practice guidelines., Methods: This systematic review was conducted on 4 critical questions, each focusing on the adoption and effectiveness of 4 intervention strategies: (1) reminders, (2) educational outreach visits, (3) audit and feedback, and (4) provider incentives. A scoping review of the Rx for Change database of systematic reviews was used to identify promising guideline implementation interventions aimed at providers. Inclusion and exclusion criteria were developed a priori for each question, and the published literature was initially searched up to 2012, and then updated with a supplemental search to 2015. Two independent reviewers screened the returned citations to identify relevant reviews and rated the quality of each included review., Results: Audit and feedback and educational outreach visits were generally effective in improving both process of care (15 of 21 reviews and 12 of 13 reviews, respectively) and clinical outcomes (7 of 12 reviews and 3 of 5 reviews, respectively). Provider incentives showed mixed effectiveness for improving both process of care (3 of 4 reviews) and clinical outcomes (3 reviews equally distributed between generally effective, mixed, and generally ineffective). Reminders showed mixed effectiveness for improving process of care outcomes (27 reviews with 11 mixed and 3 generally ineffective results) and were generally ineffective for clinical outcomes (18 reviews with 6 mixed and 9 generally ineffective results). Educational outreach visits (2 of 2 reviews), reminders (3 of 4 reviews), and provider incentives (1 of 1 review) were generally effective for cost reduction. Educational outreach visits (1 of 1 review) and provider incentives (1 of 1 review) were also generally effective for cost-effectiveness outcomes. Barriers to clinician adoption or adherence to guidelines included time constraints (8 reviews/overviews); limited staffing resources (2 overviews); timing (5 reviews/overviews); clinician skepticism (5 reviews/overviews); clinician knowledge of guidelines (4 reviews/overviews); and higher age of the clinician (1 overview). Facilitating factors included guideline characteristics such as format, resources, and end-user involvement (6 reviews/overviews); involving stakeholders (5 reviews/overviews); leadership support (5 reviews/overviews); scope of implementation (5 reviews/overviews); organizational culture such as multidisciplinary teams and low-baseline adherence (9 reviews/overviews); and electronic guidelines systems (3 reviews)., Conclusion: The strategies of audit and feedback and educational outreach visits were generally effective in improving both process of care and clinical outcomes. Reminders and provider incentives showed mixed effectiveness, or were generally ineffective. No general conclusion could be reached about cost effectiveness, because of limitations in the evidence. Important gaps exist in the evidence on effectiveness of implementation interventions, especially regarding clinical outcomes, cost effectiveness and contextual issues affecting successful implementation., (Copyright © 2017 American College of Cardiology Foundation and American Heart Association, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Industry-sponsored clinical trials produce high-quality data sets that can be used by researchers to generate new knowledge. We assessed the availability of individual participant-level data (IPD) from large cardiovascular trials conducted by major pharmaceutical companies and compiled a list of available trials., Methods and Results: We identified all randomized cardiovascular interventional trials registered on ClinicalTrials.gov with >5000 enrollment, sponsored by 1 of the top 20 pharmaceutical companies by 2014 global sales. Availability of IPD for each trial was ascertained by searching each company's website/data-sharing portal. If availability could not be determined, each company was contacted electronically. Of 60 included trials, IPD are available for 15 trials (25%) consisting of 204 452 patients. IPD are unavailable for 15 trials (25%). Reasons for unavailability were: cosponsor did not agree to make IPD available (4 trials) and trials were not conducted within a specific time (5 trials); for the remaining 6 trials, no specific reason was provided. For 30 trials (50%), availability of IPD could not be definitively determined either because of no response or requirements for a full proposal (23 trials)., Conclusions: IPD from 1 in 4 large cardiovascular trials conducted by major pharmaceutical companies are confirmed available to researchers for secondary research, a valuable opportunity to enhance science. However, IPD from 1 in 4 trials are not available, and data availability could not be definitively determined for half of our sample. For several of these trials, companies require a full proposal to determine availability, making use of the IPD by researchers less certain., (© 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Introduction: Collection of high-quality data from large populations is considered essential to generate knowledge that is critical to an era of precision medicine. Cardiovascular disease (CVD) is a leading cause of mortality in China and is a suitable focus of an initiative to discover factors that would improve our ability to assess and modify individual risk., Methods and Analysis: The pilot phase of China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Million Persons Project is being conducted during 2014-2015 in four provinces across China to demonstrate the feasibility of a population-based assessment. It is designed to screen 0.4 million community-dwelling residents aged 40-75 years with measurements of blood pressure, height and weight, a lipid blood test, and a questionnaire on cardiovascular-related health status. Participants identified at high risk of CVD receive further health assessments, including ECG, ultrasound scan, blood and urine analysis, and a questionnaire on lifestyle and medical history. Collection of blood and urine samples is used to establish a biobank. High-risk subjects are also counselled with suggestions regarding potential lifestyle changes. In addition, high-risk subjects are followed-up either in a return clinic visit or by telephone interview, with measurement of blood pressure, weight, ECG, and a questionnaire on survival status, hospitalisations and lifestyle. The first 0.1 million participants screened were used to conduct a preliminary analysis, with information on baseline characteristics, health-related behaviours, anthropometric variables, medical history, and prevalence of high-risk subjects., Ethics and Dissemination: The central ethics committee at the China National Center for Cardiovascular Disease (NCCD) approved the pilot. Written informed consent is obtained from all participants on entry into the project. Findings will be disseminated in future peer-reviewed papers and will inform strategies aimed at developing precise methods of assessing and modifying risk., Trial Registration Number: NCT02536456., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Background: Organizational learning, the process by which a group changes its behavior in response to newly acquired knowledge, is critical to outstanding organizational performance. In hospitals, strong organizational learning culture is linked with improved health outcomes for patients. This study characterizes the organizational learning culture of hospitals in China from the perspective of a cardiology service., Methods: Using a modified Abbreviated Learning Organization Survey (27 questions), we characterized organizational learning culture in a nationally representative sample of 162 Chinese hospitals, selecting 2 individuals involved with cardiovascular care at each hospital. Responses were analyzed at the hospital level by calculating the average of the two responses to each question. Responses were categorized as positive if they were 5+ on a 7-point scale or 4+ on a 5-point scale. Univariate and multiple regression analyses were used to assess the relationship between selected hospital characteristics and perceptions of organizational learning culture., Results: Of the 324 participants invited to take the survey, 316 responded (98 % response rate). Perceptions of organizational learning culture varied among items, among domains, and both among and within hospitals. Overall, the median proportion of positive responses was 82 % (interquartile range = 59 % to 93 %). "Training," "Performance Monitoring," and "Leadership that Reinforces Learning" were characterized as the most favorable domains, while "Time for Reflection" was the least favorable. Multiple regression analyses showed that region was the only factor significantly correlated with overall positive response rate., Conclusions: This nationally representative survey demonstrated variation in hospital organizational learning culture among hospitals in China. The variation was not substantially explained by hospital characteristics. Organizational learning culture domains with lower positive response rates reveal important areas for improvement.

Purpose: In China, efforts are underway to respond to rapidly increasing rates of heart disease and stroke. Yet the epidemiology of cardiovascular disease in China may be different from that of other populations. Thus, there is a critical need for population-based studies that provide insight into the risk factors, incidence and outcomes of cardiovascular disease in China. The Qingdao Port Cardiovascular Health Study is designed to investigate the burden of cardiovascular disease and the sociodemographic, biological, environmental and clinical risk factors associated with disease onset and outcomes., Participants: For this study, from 2000 through 2013, 32,404 employees aged 18 years or older were recruited from the Qingdao Port Group in China, contributing 221,923 annual health assessments. The mean age at recruitment was 43.4 (SD=12.9); 79% were male. In this ongoing study, annual health assessments, governed by extensive quality control mechanisms, include a questionnaire (capturing demographic and employment information, medical history, medication use, health behaviours and health outcomes), physical examination, ECG, and blood and urine analysis. Additional non-annual assessments include an X-ray, echocardiogram and carotid ultrasound; bio-samples will be collected for future genetic and proteomic analyses. Cardiovascular outcomes are accessed via self-report and are actively being verified with medical insurance claims; efforts are underway to adjudicate outcomes with hospital medical records., Findings to Date: Early findings reveal a significant increase in cardiovascular risk factors from 2000 to 2010 (hypertension: 26.4-39.4%; diabetes: 3.3-8.9%; hyperlipidaemia: 5.0-33.6%; body mass index >28 m/kg(2): 14.1-18.6%)., Future Plans: We aim to generate novel insights about the epidemiology and outcomes of cardiovascular disease in China, with specific emphasis on the potentially unique risk factor profiles of this Chinese population. Knowledge generated will be disseminated in the peer-reviewed literature, and will inform population-based strategies to improve cardiovascular health in China., Trial Registration Number: NCT02329886., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

China has an immediate need to address the rapidly growing population with cardiovascular disease events and the increasing number of people living with this illness. Despite progress in increasing access to services, China faces the dual challenge of addressing gaps in quality of care and producing more evidence to support clinical practice. In this Review, we address opportunities to strengthen performance measurement, programmes to improve quality of care, and national capacity to produce high-impact knowledge for clinical practice. Moreover, we propose recommendations, with implications for other diseases, for how China can immediately make use of its Hospital Quality-Monitoring System and other existing national platforms to assess and improve performance of medical care, and to generate new knowledge to inform clinical decisions and national policies., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Education, justification, and optimization are the cornerstones to enhancing the radiation safety of medical imaging. Education regarding the benefits and risks of imaging and the principles of radiation safety is required for all clinicians in order for them to be able to use imaging optimally. Empowering patients with knowledge of the benefits and risks of imaging will facilitate their meaningful participation in decisions related to their health care, which is necessary to achieve patient-centered care. Limiting the use of imaging to appropriate clinical indications can ensure that the benefits of imaging outweigh any potential risks. Finally, the continually expanding repertoire of techniques that allow high-quality imaging with lower radiation exposure should be used when available to achieve safer imaging. The implementation of these strategies in practice is necessary to achieve high-quality, patient-centered imaging and will require a shared effort and investment by all stakeholders, including physicians, patients, national scientific and educational organizations, politicians, and industry.

Background: During the past decade, efforts focused intensely on improving the quality of care for people with, or at risk for, cardiovascular disease and stroke. We sought to quantify the changes in hospitalization rates and outcomes during this period., Methods and Results: We used national Medicare data to identify all Fee-for-Service patients ≥65 years of age who were hospitalized with unstable angina, myocardial infarction, heart failure, ischemic stroke, and all other conditions from 1999 through 2011 (2010 for 1-year mortality). For each condition, we examined trends in adjusted rates of hospitalization per patient-year and, for each hospitalization, rates of 30-day mortality, 30-day readmission, and 1-year mortality overall and by demographic subgroups and regions. Rates of adjusted hospitalization declined for cardiovascular conditions (38.0% for 2011 compared with 1999 [95% confidence interval (CI), 37.2-38.8] for myocardial infarction, 83.8% [95% CI, 83.3-84.4] for unstable angina, 30.5% [95% CI, 29.3-31.6] for heart failure, and 33.6% [95% CI, 32.9-34.4] for ischemic stroke compared with 10.2% [95% CI, 10.1-10.2] for all other conditions). Adjusted 30-day mortality rates declined 29.4% (95% CI, 28.1-30.6) for myocardial infarction, 13.1% (95% CI, 1.1-23.7) for unstable angina, 16.4% (95% CI, 15.1-17.7) for heart failure, and 4.7% (95% CI, 3.0-6.4) for ischemic stroke. There were also reductions in rates of 1-year mortality and 30-day readmission and consistency in declines among the demographic subgroups., Conclusions: Hospitalizations for acute cardiovascular disease and stroke from 1999 through 2011 declined more rapidly than for other conditions. For these conditions, mortality and readmission outcomes improved., (© 2014 American Heart Association, Inc.)

The lipid component of the Action to Control Cardiovascular Risk in Diabetes (ACCORD-Lipid) trial was a landmark, publicly funded study demonstrating that fenofibrate, when added to statin therapy, was not associated with improved cardiovascular outcomes among patients with diabetes mellitus. We performed a cross-sectional study of all articles describing the results of ACCORD-Lipid in the news and biomedical literature in the 15 months following its publication. For articles published in biomedical journals, we determined whether there was an association between authors' conflicts of interest and trial interpretation. We identified 67 news articles and 141 biomedical journal articles discussing ACCORD-Lipid. Approximately 30% of news and biomedical journal articles described fenofibrate as ineffective, whereas nearly 20% concluded it was effective. Among articles making a recommendation, approximately 50% of news and 67% of biomedical journal articles supported continued fibrate use. Authors with conflicts of interest were more likely to describe fenofibrate as effective (27.1% vs 8.9%; relative risk, 3.03; 95% CI, 1.22-7.50; P = .008) and support continued fibrate use (77.4% vs 45.8%; 1.69; 1.07-2.67; P = .006). The ACCORD-Lipid trial was described inconsistently in news and biomedical journal articles, possibly creating uncertainty among patients and physicians. In addition, conflicts of interest were associated with more favorable trial interpretation.